Samples of Popular Diabetes Drug Contain Potential Carcinogen, F.D.A. Says
Testing found nitrosamine contamination in some samples of Januvia, but regulators will allow Merck to continue selling the drug for now.
Food and Drug Administration
What is Tpoxx? The Monkeypox Treatment Drug That’s Hard to Get
Doctors who want to prescribe tecovirimat, or Tpoxx, must navigate a gantlet of bureaucratic hurdles that experts say could be quickly lifted.
There’s Just One Drug to Treat Monkeypox. Good Luck Getting It.
Doctors who want to prescribe tecovirimat, or Tpoxx, must navigate a gantlet of bureaucratic hurdles that experts say could be quickly lifted.
U.S. Could Have Had Many More Doses of Monkeypox Vaccine This Year
The Department of Health and Human Services delayed asking the manufacturer to process the bulk vaccine the government already owned into vials.
U.S. Could Have Had Many More Doses of Monkeypox Vaccine This Year
The Department of Health and Human Services delayed asking the manufacturer to process the bulk vaccine the government already owned into vials.
Biden Administration Plans to Offer Updated Booster Shots in September
With reformulated shots from Pfizer and Moderna on the horizon, the F.D.A. has decided that Americans under 50 should wait to receive second boosters.
Biden Administration Plans to Offer Updated Booster Shots in September
With reformulated shots from Pfizer and Moderna on the horizon, the F.D.A. has decided that Americans under 50 should wait to receive second boosters.
Biden Administration Plans to Offer Updated Booster Shots in September
With reformulated shots from Pfizer and Moderna on the horizon, the F.D.A. has decided that Americans under 50 should wait to receive second boosters.
FDA Releases Draft Guidance on Evaluation of Therapeutic Equivalence of Approved Biologic and Small Molecule Drugs
By Kevin E. Noonan — On July 20th, the FDA released draft Guidance regarding its standards on therapeutic equivalence (TE) between both biologic and small […]
F.D.A. Seeks Outside Review of Troubled Food and Tobacco Units
The agency’s commissioner asked an external foundation to examine its operations in the wake of the baby formula and vaping crises.
Monkeypox Catches New York City Off Guard (Again)
Long lines for vaccines. Testing is slowed. Antivirals are held up. Treatment is easier for the privileged. Sound familiar?
F.D.A. to Weigh Over-the-Counter Sale of Birth Control Pills
The first U.S. application for sale of a nonprescription birth control pill has taken on new meaning after the Supreme Court decision ending the constitutional […]
F.D.A. to Weigh Over-the-Counter Sale of Birth Control Pills
The first U.S. application for sale of a nonprescription birth control pill has taken on new meaning after the Supreme Court decision ending the constitutional […]
F.D.A. to Weigh Over-the-Counter Sale of Contraceptive Pills
The first U.S. application for sale of a nonprescription birth control pill has taken on new meaning after the Supreme Court decision ending the constitutional […]
What the Biden Administration Could Do Now to Protect Abortion Rights
The most urgent step the federal government can take is to ensure access to medication abortion.
FDA temporarily suspends order banning sales of Juul
The Food and Drug Administration (FDA) on Tuesday announced it had temporarily suspended its ban on sales of the popular e-cigarette maker Juul. “On July […]
Vladimir Zelenko, 48, Dies; Promoted an Unfounded Covid Treatment
A self-described “simple country doctor,” he won national attention in 2020 when the White House embraced his hydroxychloroquine regimen.
FDA: Omicron-specific boosters must target new strains
New COVID-19 booster shots should be tailored to target omicron’s BA.4 and BA. 5 subvariants as well as the original strain in order to give […]
Behind the Scenes, McKinsey Guided Companies at the Center of the Opioid Crisis
The consulting firm offered clients “in-depth experience in narcotics,” from poppy fields to pills more powerful than Purdue’s OxyContin.
Abortion Pills Take the Spotlight as States Impose Abortion Bans
Demand for medication abortion is surging, setting the stage for new legal battles.
Two Florida Men Charged With Profiting Off Fake Prescriptions
Fifteen people have now been charged in a fraud scheme that sold drugs to treat cancer, H.I.V. and psychiatric conditions. One was charged with distributing […]
Two Florida Men Charged With Profiting Off Fake Prescriptions
Fifteen people have now been charged in a fraud scheme that sold drugs to treat cancer, H.I.V. and psychiatric conditions. One was charged with distributing […]
Two Florida Men Charged With Profiting Off Fake Prescriptions
Fifteen people have now been charged in a fraud scheme that sold drugs to treat cancer, H.I.V. and psychiatric conditions. One was charged with distributing […]
Two Florida Men Charged With Profiting Off Fake Prescriptions
Fifteen people have now been charged in a fraud scheme that sold drugs to treat cancer, H.I.V. and psychiatric conditions. One was charged with distributing […]
Two Florida Men Charged With Profiting Off Fake Prescriptions
Fifteen people have now been charged in a fraud scheme that sold drugs to treat cancer, H.I.V. and psychiatric conditions. One was charged with distributing […]
What to Know About Covid Vaccine Doses for Very Young Children
Vaccines from Pfizer and its partner BioNTech are already been available for Americans 6 and older, and Moderna’s vaccines have been approved for adults.
What to Know About Covid Vaccine Doses for Very Young Children
Vaccines from Pfizer and its partner BioNTech are already been available for Americans 6 and older, and Moderna’s vaccines have been approved for adults.
What to Know About Covid Vaccine Doses for Very Young Children
Vaccines from Pfizer and its partner BioNTech are already been available for Americans 6 and older, and Moderna’s vaccines have been approved for adults.
What to Know About Covid Vaccine Doses for Very Young Children
Vaccines from Pfizer and its partner BioNTech are already been available for Americans 6 and older, and Moderna’s vaccines have been approved for adults.
What to Know About Covid Vaccine Doses for Very Young Children
Vaccines from Pfizer and its partner BioNTech are already been available for Americans 6 and older, and Moderna’s vaccines have been approved for adults.
What’s Next on Moderna and Pfizer Vaccines for Very Young Kids?
As eagerly anticipated as the shots are for some parents, the F.D.A. advisory committee’s decisions are just one step in a process federal regulators must […]
What’s Next on Moderna and Pfizer Vaccines for Very Young Kids?
As eagerly anticipated as the shots are for some parents, the committee’s meeting is just one step in a process federal regulators must follow before […]
Un fármaco para la alopecia recibe aprobación de la FDA
El medicamento, de Eli Lilly, ya se emplea para la artritis reumatoide y, en muchos pacientes, restablece el crecimiento del cabello. Pronto podría haber otros […]
Un fármaco para la alopecia recibe aprobación de la FDA
El medicamento, de Eli Lilly, ya se emplea para la artritis reumatoide y, en muchos pacientes, restablece el crecimiento del cabello. Pronto podría haber otros […]
FDA approves alopecia treatment
The Food and Drug Administration (FDA) has approved a full-body treatment for alopecia areata, an autoimmune disorder that can cause hair loss and baldness occurring […]
New Experimental Therapy for A.L.S. Approved in Canada
The F.D.A. is also reviewing the treatment, Albrioza, but the agency’s scientists have raised questions about its effectiveness.
F.D.A. Approves Alopecia Drug That Restores Hair Growth in Many Patients
The drug, made by Eli Lilly, is already used for rheumatoid arthritis, and could be followed by two more drugs from other companies.
F.D.A. Approves Alopecia Drug That Restores Hair Growth in Many Patients
The drug, made by Eli Lilly, is already used for rheumatoid arthritis, and could be followed by two more drugs from other companies.
New Experimental Therapy for A.L.S. Approved in Canada
The F.D.A. is also reviewing the treatment, Albrioza, but the agency’s scientists have raised questions about its effectiveness.
Pfizer Vaccine Effective in Children Under 5, the F.D.A. Says
Outside experts will make their recommendations this week on how the agency should rule on applications from Pfizer and Moderna to vaccinate the nation’s youngest […]
Remission seen in every rectal cancer patient in small study of drug
A new drug called dostarlimab saw astonishing results in a 12-person rectal cancer trial: Every one of the dozen patients went into remission. All the […]
Five ways Democrats are trying to tackle the baby formula shortage
Democrats are facing rising pressure to take action on the baby formula shortage as parents struggle to feed their children due to a series of […]
Democratic senators introduce bill to avoid future formula shortages
A group of Senate Democrats introduced a bill on Thursday to protect families who rely on infant formula and other essential sources of nutrition (ESN) […]
Senators press FDA commissioner on infant formula shortage
Sens. Tammy Baldwin (D-Wis.) and John Hoeven (R-N.D.) sent a letter to Food and Drugs Administration (FDA) commissioner Dr. Robert Califf on Thursday pressing him […]
White House announces measures to ease baby formula shortage
The White House on Thursday announced new steps to try to ease the ongoing baby formula shortage, as the Biden administration fends off political attacks […]
Moderna Vaccine Provokes Strong Immune Response in Children 6 to 11
Antibody levels rose in the children who received it, suggesting the vaccine protects against infection. But the data were gathered before the arrival of Omicron.
Moderna Vaccine Provokes Strong Immune Response in Children 6 to 11
Antibody levels rose in the children who received it, suggesting the vaccine protects against infection. But the data were gathered before the arrival of Omicron.
Moderna Vaccine Provokes Strong Immune Response in Children 6 to 11
Antibody levels rose in the children who received it, suggesting the vaccine protects against infection. But the data were gathered before the arrival of Omicron.
Emergent Hid Evidence of Covid Vaccine Problems at Plant, Report Says
The report sheds new light on executives’ worries about deficiencies in the company’s quality control systems at its troubled Baltimore plant; no contaminated doses were […]
Abortion Pills Will Be the Next Battleground in a Post-Roe America
Medication abortion allows patients to terminate early pregnancies at home. Some states are moving to limit it, while others are working to expand access.
Congress Has to Ask How Much McKinsey Hurt the F.D.A.
Three critical questions to secure F.D.A. integrity.
Biogen C.E.O. to Step Down Following Launch of Alzheimer’s Drug, Aduhelm
The drug company will effectively give up on marketing Aduhelm, which comes with unproven benefits and serious safety risks.
Biogen C.E.O. to Step Down Following Launch of Alzheimer’s Drug, Aduhelm
The drug company will effectively give up on marketing Aduhelm, which comes with unproven benefits and serious safety risks.
Biogen C.E.O. to Step Down Following Launch of Alzheimer’s Drug, Aduhelm
The drug company will effectively give up on marketing Aduhelm, which comes with unproven benefits and serious safety risks.
Biogen C.E.O. to Step Down Following Launch of Alzheimer’s Drug, Aduhelm
The drug company will effectively give up on marketing Aduhelm, which comes with unproven benefits and serious safety risks.
Biogen C.E.O. to Step Down Following Launch of Alzheimer’s Drug, Aduhelm
The drug company will effectively give up on marketing Aduhelm, which comes with unproven benefit and serious safety risks.
FDA sets tentative June dates for meeting on young kids’ vaccine
The Food and Drug Administration (FDA) on Friday released tentative June dates for its advisory committee to meet to discuss authorizing COVID-19 vaccines for young […]
Moderna asks FDA to authorize vaccine for kids under 6
Moderna on Thursday asked the Food and Drug Administration to authorize its vaccine for children under six years of age, becoming the first company to […]
Lawmakers Dismiss McKinsey’s Apology on Opioid Crisis as ‘Empty’
The consulting firm’s top executive was apologetic before Congress but denied that advising both opioid manufacturers and their federal regulator posed a conflict of interest.
Lawmakers Dismiss McKinsey’s Apology on Opioid Crisis as ‘Empty’
The consulting firm’s top executive was apologetic before Congress but denied that advising both opioid manufacturers and their federal regulator posed a conflict of interest.
Lawmakers Dismiss McKinsey’s Apology on Opioid Crisis as ‘Empty’
The consulting firm’s top executive was apologetic before Congress but denied that advising both opioid manufacturers and their federal regulator posed a conflict of interest.
Lawmakers Dismiss McKinsey’s Apology on Opioid Crisis as ‘Empty’
The consulting firm’s top executive was apologetic before Congress but denied that advising both opioid manufacturers and their federal regulator posed a conflict of interest.
Vaccines for young children are being delayed by incomplete data, a top F.D.A. official suggests.
Moderna and the Pfizer-BioNTech partnership are developing versions of their coronavirus vaccines for children under 5, with emergency-use filings expected soon.
Vaccines for young children are being delayed by incomplete data, a top F.D.A. official suggests.
Moderna and the Pfizer-BioNTech partnership are developing versions of their coronavirus vaccines for children under 5, with emergency-use filings expected soon.
Florida congressman says Aduhelm’s FDA approval ‘muddied the waters’ for future Alzheimer’s drugs
Rep. Neal Dunn (R-Fla.) on Tuesday said the controversial federal approval of the Alzheimer’s medication Aduhelm “muddied the waters” for other potential treatments for the […]
Congress Has to Ask How Much McKinsey Hurt the F.D.A.
Three critical questions to secure F.D.A. integrity.
Vaccines for young children are being delayed by incomplete data, a top F.D.A. official suggests.
Moderna and the Pfizer-BioNTech partnership are developing versions of their coronavirus vaccines for children under 5, with emergency-use filings expected soon.
Congress Has to Ask How Much McKinsey Hurt the F.D.A.
Three critical questions to secure F.D.A. integrity.
FDA investigating Lucky Charms amid reports of illness
The Food and Drug Administration (FDA) says it is investigating Lucky Charms over dozens complaints it has received from customers who say they became ill […]
FDA now able to regulate e-cigarettes that use synthetic nicotine
The Food and Drug Administration (FDA) now has oversight to regulate e-cigarette products from vaping companies operating under a loophole that was closed by a […]
Pfizer Says Booster Strengthens Immune Response for Children 5 to 11
Pfizer and BioNTech will soon ask the Food and Drug Administration for emergency authorization of Covid booster doses for that age group, the companies said.
McKinsey Opened a Door in Its Firewall Between Pharma Clients and Regulators
The firm let consultants advise both drugmakers and their government overseers, internal records show. “Who we know and what we know” was part of their […]
New Drug Slashed Deaths Among Patients With Severe Covid, Maker Claims
A late-stage trial was halted after strong early results, according to the company, but outside scientists have not yet seen the data.
FDA clears Fitbit for passive heart rhythm monitoring
Google has announced that the Food and Drug Administration (FDA) has cleared its product, Fitbit, to use a new feature that will identify atrial fibrillation […]
Medicare Officially Limits Coverage of Aduhelm to Patients in Clinical Trials
Officials cited data showing the new Alzheimer’s drug has serious safety risks and may not help patients.
The F.D.A. Suspends Use of Glaxo Antibody Drug in the U.S.
Manufacturers said lab testing revealed that the authorized dosage of the drug was not sufficiently potent against BA.2.
F.D.A. Allows Second Coronavirus Boosters for Everyone 50 and Older
People in the age group can get the additional shot at least four months after their first booster. Those 12 and older with certain immune […]
Biden Administration Plans to Offer Older Americans Second Booster Shots
The plan will offer people 65 and older — and possibly some younger adults — the option of another booster, in case infections surge again […]
F.D.A. Rushed a Drug for Preterm Births. Did It Put Speed Over Science?
The agency’s accelerated approval program for certain drugs has come under intense scrutiny because some medicines stay on the market despite limited evidence that they […]
F.D.A.’s Accelerated Drug Approvals Come Under Scrutiny
A drug to prevent preterm birth may provide the next test of the agency’s process for speedily getting drugs on the market, despite limited evidence […]
Moderna to Seek Authorization of Its Coronavirus Vaccine for Young Children
The company said the vaccine produced a strong immune response in children younger than 6, but proved only about 40 percent effective in preventing symptomatic […]
Pfizer Recalls Some Blood Pressure Drugs, Citing Cancer Risk
The move follows recalls of other medications found to have higher levels of potential carcinogens.
Pfizer Recalls Some Blood Pressure Drugs, Citing Cancer Risk
The move follows recalls of other medications found to have higher levels of potential carcinogens.
Pfizer Recalls Some Blood Pressure Drugs, Citing Cancer Risk
The move follows recalls of other medications found to have higher levels of potential carcinogens.
FDA Rejects India-Made Bharat Biotech Vaccine For Those Under 18
The vaccine, made by Bharat Biotech, is widely used in India. It has not been tested in the U.S., which has not authorized it for […]
FDA Rejects India-Made Bharat Biotech Vaccine For Those Under 18
The vaccine, made by Bharat Biotech, is widely used in India. It has not been tested in the U.S., which has not authorized it for […]
FDA Rejects India-Made Bharat Biotech Vaccine For Those Under 18
The vaccine, made by Bharat Biotech, is widely used in India. It has not been tested in the U.S., which has not authorized it for […]
FDA Rejects India-Made Bharat Biotech Vaccine For Those Under 18
The vaccine, made by Bharat Biotech, is widely used in India. It has not been tested in the U.S., which has not authorized it for […]
Senate Confirms Califf as F.D.A. Chief in Tight Vote
The narrow 50-46 decision underscored the divisions on both sides of the aisle over agency policies on opioids and abortion medications and his ties to […]
The Next Vaccine Debate: Immunize Young Children Now, or Wait?
It’s not clear whether three doses of the Pfizer-BioNTech vaccine will adequately protect young children. But the F.D.A. may authorize the first two doses anyway.
F.D.A Delays Review of Pfizer’s Covid Vaccine for Children Under 5
The agency will wait for data on whether three doses of Pfizer-BioNTech’s Covid vaccine are effective in young children after new, disappointing data.
F.D.A. Clears Monoclonal Antibody Drug From Eli Lilly
The federal government has ordered 600,000 doses of the monoclonal antibody treatment, which is meant for high-risk Covid patients early in their illness.
F.D.A. Clears Monoclonal Antibody Drug From Eli Lilly
The federal government has ordered 600,000 doses of the monoclonal antibody treatment, which is meant for high-risk Covid patients early in their illness.
¿Vacunar a los niños pequeños o esperar?
No está claro si tres dosis de la vacuna Pfizer-BioNTech protegerán adecuadamente a los niños. Pero es posible que la FDA autorice las primeras dos […]
¿Vacunar a los niños pequeños o esperar?
No está claro si tres dosis de la vacuna Pfizer-BioNTech protegerán adecuadamente a los niños. Pero es posible que la FDA autorice las primeras dos […]
FDA Panel Rejects Lilly’s Cancer Drug Tested Only in China
The panel debated whether overseas trials could be applied to a more diverse U.S. population. The decision may affect other Chinese drug trials, and spotlights […]
FDA Panel Rejects Lilly’s Cancer Drug Tested Only in China
The panel debated whether overseas trials could be applied to a more diverse U.S. population. The decision may affect other Chinese drug trials, and spotlights […]
The Next Vaccine Debate: Immunize Young Children Now, or Wait?
It’s not clear whether three doses of the Pfizer-BioNTech vaccine will adequately protect young children. But the F.D.A. may authorize the first two doses anyway.
Pennsylvania Doctor Accused of Prescribing Ivermectin for Covid Is Fired
Tower Health Medical Group said in a statement that it learned of the allegations on Wednesday. After an investigation, the doctor’s employment was “terminated effective […]
Pennsylvania Doctor Accused of Prescribing Ivermectin for Covid Is Fired
Tower Health Medical Group said in a statement that it learned of the allegations on Wednesday. After an investigation, the doctor’s employment was “terminated effective […]
FDA Approves Generic Restasis
By Kevin E. Noonan — On Wednesday, the U.S. Food and Drug Administration announced approval to Mylan Pharmaceuticals for a generic form of Allergan’s RESTASIS® […]
F.D.A. Nominee Faces Steep Climb to Senate Confirmation
Dr. Robert Califf, a former agency commissioner, is encountering opposition over federal opioid and abortion policies and his industry ties.
F.D.A. Nominee Faces Steep Climb to Senate Confirmation
Dr. Robert Califf, a former agency commissioner, is encountering opposition over federal opioid and abortion policies and his industry ties.
F.D.A. Approves Remdesivir for Patients Not Hospitalized
The treatment must be given via intravenous infusion over three consecutive days, generally at a hospital or clinic.
Detainees Sue Arkansas Jail That Gave Them Ivermectin to Treat Covid
For months, the jail’s doctor has promoted the drug, which health experts say should not be used to treat or prevent Covid-19.
Senate Panel OKs Califf Nomination for F.D.A. Chief
A split committee vote revealed concerns about the opioid epidemic and abortion policies, foreshadowing a likely close vote on confirmation by the full Senate.
Senate Panel OKs Califf Nomination for F.D.A. Chief
A split committee vote revealed concerns about the opioid epidemic and abortion policies, foreshadowing a likely close vote on confirmation by the full Senate.
Senate Panel OKs Califf Nomination for F.D.A. Chief
A key committee was split mainly on party lines over the nomination of Dr. Robert Califf, foreshadowing divisions in the full Senate for a vote […]
FDA Biosimilar Approval Recap – 2021
By Kevin E. Noonan — The U.S. Food and Drug Administration approved four biosimilar drugs in 2021 under the provisions of the Biologics Price Competition […]
F.D.A. Plans to Allow 12- to 15-Year-Olds to Receive Pfizer Boosters
Regulators will also allow even younger children with immune deficiencies to get an extra shot.
Merck’s Covid Pill Is Authorized by F.D.A. for High-Risk Adults
The F.D.A. said the drug should be prescribed mainly when other treatments were “not accessible or clinically appropriate.”
Merck’s Covid Pill Is Authorized by F.D.A. for High-Risk Adults
The F.D.A. said the drug should be prescribed mainly when other treatments were “not accessible or clinically appropriate.”
Merck’s Covid Pill Is Authorized by F.D.A. for High-Risk Adults
The F.D.A. said the drug should be prescribed mainly when other treatments were “not accessible or clinically appropriate.”
Merck’s Covid Pill Is Authorized by F.D.A. for High-Risk Adults
The F.D.A. said the drug should be prescribed mainly when other treatments were “not accessible or clinically appropriate.”
Merck’s Covid Pill Is Authorized by F.D.A. for High-Risk Adults
The F.D.A. said the drug should be prescribed mainly when other treatments were “not accessible or clinically appropriate.”
Beneath a Covid Vaccine Debacle, 30 Years of Government Culpability
Washington has rejected plans to revamp vaccine preparedness for decades and repeatedly paid a price. The Biden administration is at a similar crossroads.
Beneath a Covid Vaccine Debacle, 30 Years of Government Culpability
Washington has rejected plans to revamp vaccine preparedness for decades and repeatedly paid a price. The Biden administration is at a similar crossroads.
Beneath a Covid Vaccine Debacle, 30 Years of Government Culpability
Washington has rejected plans to revamp vaccine preparedness for decades and repeatedly paid a price. The Biden administration is at a similar crossroads.
Beneath a Covid Vaccine Debacle, 30 Years of Government Culpability
Washington has rejected plans to revamp vaccine preparedness for decades and repeatedly paid a price. The Biden administration is at a similar crossroads.
Merck’s Covid Pill Is Authorized by F.D.A. for High-Risk Adults
The F.D.A. said the drug should be prescribed mainly when other treatments were “not accessible or clinically appropriate.”
Beneath a Covid Vaccine Debacle, 30 Years of Government Culpability
Washington has rejected plans to revamp vaccine preparedness for decades and repeatedly paid a price. The Biden administration is at a similar crossroads.
Beneath a Covid Vaccine Debacle, 30 Years of Government Culpability
Washington has rejected plans to revamp vaccine preparedness for decades and repeatedly paid a price. The Biden administration is at a similar crossroads.
F.D.A. Clears Pfizer’s Covid Pill for High-Risk Patients 12 and Older
The first-of-its-kind treatment, Paxlovid, has been found to be highly protective against severe illness. It could be available within a few days.
F.D.A. Clears Pfizer’s Covid Pill for High-Risk Patients 12 and Older
The first-of-its-kind treatment, Paxlovid, has been found to be highly protective against severe illness. It could be available within a few days.
F.D.A. Clears Pfizer’s Covid Pill for High-Risk Patients 12 and Older
The first-of-its-kind treatment, Paxlovid, has been found to be highly protective against severe illness. It could be available within a few days.
F.D.A. Clears Pfizer’s Covid Pill for High-Risk Patients 12 and Older
The first-of-its-kind treatment, Paxlovid, has been found to be highly protective against severe illness. It could be available within a few days.
F.D.A. Clears Pfizer’s Covid Pill for High-Risk Patients 12 and Older
The first-of-its-kind treatment, Paxlovid, has been found to be highly protective against severe illness. It could be available within a few days.
Biogen Slashes Price of Alzheimer’s Drug Aduhelm, as It Faces Obstacles
A group of Alzheimer’s experts and health advocates called on the F.D.A. to withdraw its approval of the drug, the latest of several setbacks for […]
Biogen Slashes Price of Alzheimer’s Drug Aduhelm, as It Faces Obstacles
A group of Alzheimer’s experts and health advocates called on the F.D.A. to withdraw its approval of the drug, the latest of several setbacks for […]
Biogen Slashes Price of Alzheimer’s Drug Aduhelm, as It Faces Obstacles
A group of Alzheimer’s experts and health advocates called on the F.D.A. to withdraw its approval of the drug, the latest of several setbacks for […]
Biogen Slashes Price of Alzheimer’s Drug Aduhelm, as It Faces Obstacles
A group of Alzheimer’s experts and health advocates called on the F.D.A. to withdraw its approval of the drug, the latest of several setbacks for […]
F.D.A. Will Permanently Allow Abortion Pills by Mail
The decision will broaden access to medication abortion, an increasingly common method, but many conservative states are already mobilizing against it.
F.D.A. Will Permanently Allow Abortion Pills by Mail
The decision will broaden access to medication abortion, an increasingly common method, but many conservative states are already mobilizing against it.
Senators Question Califf, the F.D.A. Nominee, on Opioid Crisis and Pandemic Response
A Senate panel hearing on Tuesday signaled that Dr. Robert Califf, who briefly led the agency during the Obama administration, had some bipartisan support.
Senators Question Califf, the F.D.A. Nominee, on Opioid Crisis and Pandemic Response
A Senate panel hearing on Tuesday signaled that Dr. Robert Califf, who briefly led the agency during the Obama administration, had some bipartisan support.
Senators Question Califf, the F.D.A. Nominee, on Opioid Crisis and Pandemic Response
A Senate panel hearing on Tuesday signaled that Dr. Robert Califf, who briefly led the agency during the Obama administration, had some bipartisan support.
Senators Question Califf, the F.D.A. Nominee, on Opioid Crisis and Pandemic Response
A Senate panel hearing on Tuesday signaled that Dr. Robert Califf, who briefly led the agency during the Obama administration, had some bipartisan support.
Firms Push for Over-the-Counter Access to Birth-Control Pills
Two drugmakers have been mired for years in the pre-application phase of getting F.D.A. approval for over-the-counter use.
Firms Push for Over-the-Counter Access to Birth-Control Pills
Two drugmakers have been mired for years in the pre-application phase of getting F.D.A. approval for over-the-counter use.
Firms Push for Over-the-Counter Access to Birth-Control Pills
Two drug makers have been mired for years in the pre-application phase of getting F.D.A. approval for over-the-counter use.
Merck’s Covid Pill Might Pose Risks for Pregnant Women
Some laboratory studies suggest that molnupiravir can insert errors in DNA, which could in theory harm a developing fetus, sperm cells or children.
Merck’s Covid Pill Might Pose Risks for Pregnant Women
Some laboratory studies suggest that molnupiravir can insert errors in DNA, which could in theory harm a developing fetus, sperm cells or children.
F.D.A. Authorizes AstraZeneca Drug for People With Immune Problems
The antibody drug, Evusheld, was found to be strongly effective in preventing Covid in a clinical trial that enrolled mostly those at high risk.
F.D.A. Authorizes AstraZeneca Drug for People With Immune Problems
The antibody drug, Evusheld, was found to be strongly effective in preventing Covid in a clinical trial that enrolled mostly those at high risk.
Los nuevos antivirales para la covid ofrecen esperanza frente a la variante ómicron
Merck y Pfizer están por presentar sus pastillas de prescripción para tratar la COVID-19. Vienen más fármacos en camino.
Los nuevos antivirales para la covid ofrecen esperanza frente a la variante ómicron
Merck y Pfizer están por presentar sus pastillas de prescripción para tratar la COVID-19. Vienen más fármacos en camino.
Los nuevos antivirales para la covid ofrecen esperanza frente a la variante ómicron
Merck y Pfizer están por presentar sus pastillas de prescripción para tratar la COVID-19. Vienen más fármacos en camino.
New Covid Antiviral Pills Offer Hope as Omicron Looms
Merck and Pfizer will soon debut prescription pills to treat Covid-19. And more drugs are on the way.
New Covid Antiviral Pills Offer Hope as Omicron Looms
Merck and Pfizer will soon debut prescription pills to treat Covid-19. And more drugs are on the way.
Merck’s Covid Treatment Pill Wins Blessing of F.D.A. Panel
The treatment, known as molnupiravir, could be authorized in the United States within days, and available within weeks, if the F.D.A. follows the committee’s recommendation.
Merck’s Covid Treatment Pill Wins Blessing of F.D.A. Panel
The treatment, known as molnupiravir, could be authorized in the United States within days, and available within weeks, if the F.D.A. follows the committee’s recommendation.
Merck’s Covid Treatment Pill Wins Blessing of F.D.A. Panel
The treatment, known as molnupiravir, could be authorized in the United States within days, and available within weeks, if the F.D.A. follows the committee’s recommendation.
Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many […]
Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many […]
Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many […]
Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many […]
Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many […]
Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many […]
F.D.A. Authorizes Coronavirus Booster Shots for All Adults
If the C.D.C. agrees, adults who received a second shot of the Pfizer or Moderna vaccine at least six months ago could be eligible by […]
F.D.A. Authorizes Coronavirus Booster Shots for All Adults
If the C.D.C. agrees, adults who received a second shot of the Pfizer or Moderna vaccine at least six months ago could be eligible by […]
F.D.A. Authorizes Coronavirus Booster Shots for All Adults
If the C.D.C. agrees, adults who received a second shot of the Pfizer or Moderna vaccine at least six months ago could be eligible by […]
F.D.A. Authorizes Coronavirus Booster Shots for All Adults
If the C.D.C. agrees, adults who received a second shot of the Pfizer or Moderna vaccine at least six months ago could be eligible by […]
F.D.A. Authorizes Covid Booster Shots for All Adults
The Food and Drug Administration authorized Pfizer-BioNTech and Moderna vaccine boosters for those 18 and older, in preparation for holiday travel and cold winter months.
F.D.A. Authorizes Covid Booster Shots for All Adults
The Food and Drug Administration authorized Pfizer-BioNTech and Moderna vaccine boosters for those 18 and older, in preparation for holiday travel and cold winter months.
F.D.A. Authorizes Covid Booster Shots for All Adults
The Food and Drug Administration authorized Pfizer-BioNTech and Moderna vaccine boosters for those 18 and older, in preparation for holiday travel and cold winter months.
F.D.A. Authorizes Covid Booster Shots for All Adults
The Food and Drug Administration authorized Pfizer-BioNTech and Moderna vaccine boosters for those 18 and older, in preparation for holiday travel and cold winter months.
F.D.A. Authorizes Covid Booster Shots for All Adults
The Food and Drug Administration authorized Pfizer-BioNTech and Moderna vaccine boosters for those 18 and older, in preparation for holiday travel and cold winter months.
F.D.A. Authorizes Covid Booster Shots for All Adults
The Food and Drug Administration authorized Pfizer-BioNTech and Moderna vaccine boosters for those 18 and older, in preparation for holiday travel and cold winter months.
F.D.A. Authorizes Coronavirus Booster Shots for All Adults
If the C.D.C. agrees, adults who received a second shot of the Pfizer or Moderna vaccine at least six months ago could be eligible by […]
Pfizer Asks F.D.A. to Authorize Covid Pill For High-Risk Unvaccinated People
The treatment, Paxlovid, is the second antiviral pill to show effectiveness in treating Covid.
Pfizer Asks F.D.A. to Authorize Covid Pill For High-Risk Unvaccinated People
. The request is for use in unvaccinated, high risk patients. But the regulator could authorize it for broader use.
Pfizer Asks F.D.A. to Authorize Covid Pill For High-Risk Unvaccinated People
. The request is for use in unvaccinated, high risk patients. But the regulator could authorize it for broader use.
U.S. to Buy Enough of Pfizer’s Covid Antiviral Pills for 10 Million People
The antiviral drugs have helped inspire hope among senior administration officials that the United States will be able to curb the devastating toll from the […]
U.S. to Buy Enough of Pfizer’s Covid Antiviral Pills for 10 Million People
The antiviral drugs have helped inspire hope among senior administration officials that the United States will be able to curb the devastating toll from the […]
U.S. to Buy Enough of Pfizer’s Covid Antiviral Pills for 10 Million People
The antiviral drugs have helped inspire hope among senior administration officials that the United States will be able to curb the devastating toll from the […]
U.S. to Buy Enough of Pfizer’s Covid Antiviral Pills for 10 Million People
The antiviral drugs have helped inspire hope among senior administration officials that the United States will be able to curb the devastating toll from the […]
F.D.A. Plans to Authorize Pfizer Boosters for All Adults This Week
Regulators are set to clear extra doses of Pfizer-BioNTech’s vaccine as soon as Thursday, after states began expanding eligibility on their own.
Pfizer Asks F.D.A. to Authorize Covid Pill For High-Risk Unvaccinated People
. The request is for use in unvaccinated, high risk patients. But the regulator could authorize it for broader use.
Pfizer Says Its Antiviral Pill Is Highly Effective in Treating Covid
Pfizer’s is the second pill to show effectiveness against Covid-19, and it is the first purpose-built to attack the virus that causes the disease.
U.S. to Buy Enough of Pfizer’s Covid Antiviral Pills for 10 Million People
The antiviral drugs have helped inspire hope among senior administration officials that the United States will be able to curb the devastating toll from the […]
Pfizer Asks F.D.A. to Authorize Covid Pill For Unvaccinated People
The treatment, Paxlovid, is the second antiviral pill to show effectiveness in treating Covid, and works differently from the first.
Biden Chooses Robert Califf to Lead F.D.A., Despite Drug Industry Ties
Dr. Robert M. Califf, an academic and clinical trial researcher who ran the agency in 2016, has also consulted for pharmaceutical companies.
Biden Chooses Robert Califf to Lead F.D.A., Despite Drug Industry Ties
Dr. Robert M. Califf, an academic and clinical trial researcher who ran the agency in 2016, has also consulted for pharmaceutical companies.
Biden Chooses Robert Califf to Lead F.D.A., Despite Drug Industry Ties
Dr. Robert M. Califf, an academic and clinical trial researcher who ran the agency in 2016, has also consulted for pharmaceutical companies.
Biden to Choose Robert Califf to Lead F.D.A., Despite Drug Industry Ties
Dr. Robert M. Califf, an academic and clinical trial researcher who ran the agency in 2016, has also consulted for pharmaceutical companies.
FDA Issues Final and Draft Guidances on Biosimilar Development under BPCIA
By Kevin E. Noonan — In September, the U.S. Food and Drug Administration issued Final Guidance entitled “Questions and Answers on Biosimilar Development and the […]
FDA Issues Final and Draft Guidances on Biosimilar Development under BPCIA
By Kevin E. Noonan — In September, the U.S. Food and Drug Administration issued Final Guidance entitled "Questions and Answers on Biosimilar Development and the […]
Pfizer Says Its Antiviral Pill Is Highly Effective in Treating Covid
Pfizer’s is the second pill to show effectiveness against Covid-19, and it is the first purpose-built to attack the virus that causes the disease.
Pfizer Says Its Antiviral Pill Is Highly Effective in Treating Covid
Pfizer’s is the second pill to show effectiveness against Covid-19, and it is the first purpose-built to attack the virus that causes the disease.
Pfizer Says Its Antiviral Pill Is Highly Effective in Treating Covid
Pfizer’s is the second pill to show effectiveness against Covid-19, and it is the first purpose-built to attack the virus that causes the disease.
What Happens Next as F.D.A., C.D.C. Weigh Covid Shots for Children
Once the experts weigh in, the Food and Drug Administration itself makes a decision and then a similar process happens at the Centers for Disease […]
Pfizer Says Its Vaccine Is Highly Protective in Children 5 to 11
The findings could add momentum for F.D.A. authorization of the pediatric dose, perhaps next week, a long-awaited development that would affect 28 million children.
FDA Approves Another Interchangeable Biosimilar Drug
By Kevin E. Noonan — On October 15th, the Food and Drug Administration approved its second interchangeable biosimilar drug. That drug is Cyltezo (adalimumab-adbm), produced […]
Qué pasa si combino vacunas en la dosis de refuerzo
La FDA podría autorizar dosis de refuerzo de vacunas diferentes de los que los estadounidenses recibieron en sus primeras dosis. Hay evidencia científica prometedora que […]
Qué pasa si combino vacunas en la dosis de refuerzo
La FDA podría autorizar dosis de refuerzo de vacunas diferentes de los que los estadounidenses recibieron en sus primeras dosis. Hay evidencia científica prometedora que […]
F.D.A. Authorizes Moderna and Johnson & Johnson Booster Shots
The agency will also allow vaccine recipients to pick which vaccine they want as a booster, endorsing a mix-and-match approach.
F.D.A. Authorizes Moderna and Johnson & Johnson Booster Shots
The agency will also allow vaccine recipients to pick which vaccine they want as a booster, endorsing a mix-and-match approach.
Sales of Biogen’s Alzheimer’s Drug Fall Short of Expectations
The drug, Aduhelm, brought in $300,000 in revenue in its first full three months of availability. The company expects the drug to generate minimal revenue […]
Sales of Biogen’s costly new Alzheimer’s drug fall far short of expectations.
The drug, Aduhelm, brought in $300,000 in revenue in its first full three months of availability. The company expects the drug to generate minimal revenue […]
Mix-and-Match Covid Boosters: Why They Just Might Work
The F.D.A. may authorize booster shots of vaccines different from the ones that Americans originally received. The science behind the move is promising.
Mix-and-Match Covid Boosters: Why They Just Might Work
The F.D.A. may authorize booster shots of vaccines different from the ones that Americans originally received. The science behind the move is promising.
F.D.A. to Allow ‘Mix and Match’ Approach for Covid Booster Shots
The agency may act this week, when it is expected to authorize booster shots for recipients of the Moderna and Johnson & Johnson vaccines.
Where Things Stand on Boosters for Three Vaccines in the U.S.
Confused about who can get a booster shot of which vaccine, and what the F.D.A.’s advisers on vaccines voted on this week? This scorecard may […]
Where Things Stand on Boosters for Three Vaccines in the U.S.
Confused about who can get a booster shot of which vaccine, and what the F.D.A.’s advisers on vaccines voted on this week? This scorecard may […]
F.D.A. Panel Recommends Moderna Booster for Certain Groups
Those eligible for the extra shot would include adults over 65 and others at high risk — the same groups now eligible for a Pfizer-BioNTech […]
F.D.A. Panel Greenlights Moderna Boosters for High-Risk Individuals
A Food and Drug Administration advisory panel recommended a half-dose as a third injection for people 65 and older as well as younger adults at […]
F.D.A. Panel Greenlights Moderna Boosters for High-Risk Individuals
A Food and Drug Administration advisory panel recommended a half-dose as a third injection for people 65 and older as well as younger adults at […]
F.D.A. Panel Greenlights Moderna Boosters for High-Risk Individuals
A Food and Drug Administration advisory panel recommended a half-dose as a third injection for people 65 and older as well as younger adults at […]
F.D.A. Panel Greenlights Moderna Boosters for High-Risk Individuals
A Food and Drug Administration advisory panel recommended a half-dose as a third injection for people 65 and older as well as younger adults at […]
Where Things Stand on Boosters for Three Vaccines in the U.S.
Confused about who can get a booster shot of which vaccine, and what the F.D.A.’s advisers on vaccines are voting on this week? This scorecard […]
Where Things Stand on Boosters for Three Vaccines in the U.S.
Confused about who can get a booster shot of which vaccine, and what the F.D.A.’s advisers on vaccines are voting on this week? This scorecard […]
F.D.A. Vaccine Booster Panel: Here’s Who Is on the Roster
The experts’ recommendations, though not binding, are likely to influence what the Food and Drug Administration decides on whether to authorize the boosters.
Where Things Stand on Boosters for Three Vaccines in the U.S.
Confused about who can get a booster shot of which vaccine, and what the F.D.A.’s advisers on vaccines are voting on this week? This scorecard […]
Merck Asks F.D.A. for Emergency Approval of Covid Pill
The company is seeking federal sign-off for the pill to be given to high-risk people sick with Covid. Tens of millions of Americans could be […]
Merck Asks F.D.A. for Emergency Approval of Covid Pill
The company is seeking federal sign-off for the pill to be given to high-risk people sick with Covid. Tens of millions of Americans could be […]
Merck Asks F.D.A. for Emergency Approval of Covid Pill
The company is seeking federal sign-off for the pill to be given to high-risk people sick with Covid. Tens of millions of Americans could be […]
Merck Asks F.D.A. for Emergency Approval of Covid Pill
The company is seeking federal sign-off for the pill to be given to high-risk people sick with Covid. Tens of millions of Americans could be […]
Coronavirus Briefing: What Happened Today
Moderna sells its vaccine almost exclusively to wealthy countries.
Coronavirus Briefing: What Happened Today
Moderna sells its vaccine almost exclusively to wealthy countries.
Coronavirus Briefing: What Happened Today
Moderna sells its vaccine almost exclusively to wealthy countries.
Coronavirus Briefing: What Happened Today
Moderna sells its vaccine almost exclusively to wealthy countries.
Coronavirus Briefing: What Happened Today
Moderna sells its vaccine almost exclusively to wealthy countries.
Merck Asks F.D.A. for Emergency Approval of Covid Pill
The company is seeking authorization for the pill to be given to high-risk people sick with Covid. Tens of millions of Americans could be eligible.
Pfizer Asks F.D.A. to Authorize Its Covid-19 Vaccine for Children 5 to 11
The agency has promised to move quickly on the request and has tentatively scheduled a meeting at the end of the month to consider it.
Johnson & Johnson to Seek F.D.A. Authorization for Booster Shot
The request, expected this week, comes after a study found the company’s vaccine was only 71 percent effective against hospitalization from Covid-19.
La píldora contra la covid: así es como funciona
Las píldoras son eficaces y relativamente baratas, pero es poco probable que estén disponibles para todos los enfermos de covid.
La píldora contra la covid: así es como funciona
Las píldoras son eficaces y relativamente baratas, pero es poco probable que estén disponibles para todos los enfermos de covid.
La píldora contra la covid: así es como funciona
Las píldoras son eficaces y relativamente baratas, pero es poco probable que estén disponibles para todos los enfermos de covid.
Johnson & Johnson to Seek F.D.A. Authorization for Booster Shot
The request, expected this week, comes after a study found the company’s vaccine was only 71 percent effective against hospitalization from Covid-19.
Merck Says It Has the First Antiviral Pill Found to Be Effective Against Covid
The drug maker will seek authorization for molnupiravir, the first drug of its kind for Covid. Experts said such pills could be a powerful tool […]
Was the Decision on Boosters Bungled?
Readers discuss the government’s handling of the issue. Also: Abortion stories; criminal justice reform; voice recognition; extinct species.
What You Need to Know About Molnupiravir, Merck’s Covid Treatment Pill
The pills are effective and relatively cheap, but they are unlikely to be available for everyone with Covid.
La desinformación sobre la covid genera la escasez de ivermectina, un medicamento para animales
El mundo agropecuario lucha contra la creciente demanda de ivermectina, un medicamento antiparasitario que las redes de desinformación aseguran, sin pruebas, que ayuda contra el […]
How Covid Misinformation Created a Run on Animal Medicine
Veterinarians, ranchers and farmers say they are struggling with the effects of the surging demand for ivermectin, a deworming drug.
FDA Approves Biosimilar Drug for Treating Macular Degeneration
By Kevin E. Noonan — The U.S. Food and Drug Administration approved the first biosimilar drug for treating macular degeneration under the provisions of the […]
Study of Covid Booster Shot Benefits Fans Debate Over Extra Doses
Independent experts, including government scientists, were skeptical of the research from Israel, which included limited data over a short period.
Study of Covid Booster Shot Benefits Fans Debate Over Extra Doses
Independent experts, including government scientists, were skeptical of the research from Israel, which included limited data over a short period.
Study of Booster Shot Benefits Fans Debate Over Extra Doses
Independent experts, including government scientists, were skeptical of the research from Israel, which included limited data over a short period.
Ohio Judge Reverses Order Requiring Covid Patient to Be Given Ivermectin
An intubated patient was prescribed the deworming drug by his doctor. Federal health officials have said that it has not been shown to be effective […]
F.D.A. Needs to Be More Critical of the Industry It Oversees
The agency that regulates drug safety has become too cozy with the industry it’s supposed to oversee.
F.D.A. Needs to Be More Critical of the Industry It Oversees
The agency that regulates drug safety has become too cozy with the industry it’s supposed to oversee.
Ivermectin Won’t Treat Covid-19, but Demand Is High Anyway
The drug has spared hundreds of millions of Africans from serious parasites, but clinical trials have repeatedly failed to show that it is effective against […]
House Committees Demand F.D.A. Records on Alzheimer’s Drug Approval
The agency approved Biogen’s Aduhelm “despite concerns raised by experts,” committee leaders said in a letter.
House Committees Demand F.D.A. Records on Alzheimer’s Drug Approval
The agency approved Biogen’s Aduhelm “despite concerns raised by experts,” committee leaders said in a letter.
House Committees Demand F.D.A. Records on Alzheimer’s Drug Approval
The agency approved Biogen’s Aduhelm “despite concerns raised by experts,” committee leaders said in a letter.
America Desperately Needs a Much Better F.D.A.
The agency that regulates drug safety has become too cozy with the industry it’s supposed to oversee.
The Intolerable Wait for a Kids’ Vaccine
As children’s hospital beds fill up, the F.D.A. shouldn’t delay.
The Intolerable Wait for a Kids’ Vaccine
As children’s hospital beds fill up, the F.D.A. shouldn’t delay.
Ivermectin Should Not Be Used to Treat Covid, F.D.A. Says
“You are not a horse,” the Food and Drug Administration said. “Stop it.”
F.D.A. Fully Approves Pfizer Vaccine
The move was expected to kick off a round of new vaccination mandates from hospitals, schools and private companies.
