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.
The move was expected to kick off a round of new vaccination mandates from hospitals, schools and private companies.
The move was expected to kick off a round of new vaccination mandates from hospitals, schools and private companies.
“You are not a horse,” the Food and Drug Administration said. “Stop it.”
“You are not a horse,” the Food and Drug Administration said. “Stop it.”
For an increasingly important set of drugs, Medicare has been driving up prices. It knows how to do better.
For an increasingly important set of drugs, Medicare has been driving up prices. It knows how to do better.
The added dose will bolster protection for people who have weakened immune systems because of cancer treatments, transplant surgery and other medical interventions.
A top White House adviser said monoclonal antibody treatments, sometimes underused, could still be crucial in helping people with Covid-19 avoid getting very sick.
A top White House adviser said monoclonal antibody treatments, sometimes underused, could still be crucial in helping people with Covid-19 avoid getting very sick.
Jazz Pharmaceuticals brought in more than $1.7 billion last year selling GHB to narcolepsy patients. With the new approval, sales could soar.
Jazz Pharmaceuticals brought in more than $1.7 billion last year selling GHB to narcolepsy patients. With the new approval, sales could soar.
Michael Pollan discusses his psychedelic journey and what highly processed foods are doing to our bodies.
The author discusses his psychedelic journey and why the government embraces some drugs while waging a war against others.
Boosters may not be necessary yet, many experts say, and the pursuit of additional shots raises ethical questions.
By Kevin E. Noonan — Last week the U.S. Food and Drug Administration approved an interchangeable biosimilar to insulin glargine, an approval notable because it […]
The Food and Drug Administration’s move is expected to kick off more vaccination mandates for hospital workers, college students and federal troops.
The Food and Drug Administration’s move is expected to kick off more vaccination mandates for hospital workers, college students and federal troops.
Emergent BioSolutions, which ruined 75 million vaccine doses at its Baltimore plant, disclosed records requests from Congress and federal and state law enforcement agencies.
Emergent BioSolutions, which ruined 75 million vaccine doses at its Baltimore plant, disclosed records requests from Congress and federal and state law enforcement agencies.
The decision comes after state health officials were worried that doses of the company’s coronavirus shots would expire and go to waste.
The decision comes after state health officials were worried about whether doses of the Johnson & Johnson coronavirus vaccine would expire and go to waste.
The F.D.A. wants Pfizer and Moderna to increase the number of 5- to 11-year-olds who participate in trials of their coronavirus vaccines to ensure there […]
Muchos de los que recibieron la vacuna pueden necesitar refuerzos, dijeron los autores. Pero las autoridades sanitarias federales no recomiendan segundas dosis.
Muchos de los que recibieron la vacuna pueden necesitar refuerzos, dijeron los autores. Pero las autoridades sanitarias federales no recomiendan segundas dosis.
Research into these often mysterious and debilitating disorders has languished. That’s changing.
The drug from Biogen, called Aduhelm, is expected to generate billions in sales. It could also strain Medicare’s budget within a few years.
The drug from Biogen, called Aduhelm, is expected to generate billions in sales. It could also strain Medicare’s budget within a few years.
Many who received the shot may need to consider boosters, the authors said. But federal health officials do not recommend second doses.
Many who received the shot may need to consider boosters, the authors said. But federal health officials do not recommend second doses.
Though some of its own senior officials said there was little evidence of benefit for patients, the F.D.A. nonetheless greenlighted Biogen’s Aduhelm, or aducanumab.
Though some of its own senior officials said there was little evidence of benefit for patients, the F.D.A. nonetheless greenlighted Biogen’s Aduhelm, or aducanumab.
The Delta variant has accelerated conversations about introducing booster doses of coronavirus vaccines.
The Delta variant has accelerated conversations about introducing booster doses of coronavirus vaccines.
The major medical center’s rejection of the new Alzheimer’s drug is one of the starkest signs of concern over its effectiveness.
After meeting with company representatives, officials said the decision would depend partly on data on infections in vaccinated people that cause serious disease or hospitalization.
Federal regulators concluded that the risk of developing the syndrome was low, and that the benefits of the vaccine still strongly outweigh it.
The agency’s acting head said a review should look into whether any interactions between agency staff and the drug developer, Biogen, broke F.D.A. rules.
The agency faced criticism for approving Aduhelm for all Alzheimer’s patients. Now it recommends that the drug be given only to those with mild symptoms.
The agency faced criticism for approving Aduhelm for all Alzheimer’s patients. The new label recommends that the drug be given only to patients with mild […]
The F.D.A. shocked the world of medicine when it approved a much-debated drug for Alzheimer’s. What does the decision mean for patients and their families?
The F.D.A. shocked the world of medicine when it approved a much-debated drug for the disease. What does the decision mean for patients and their […]
Some public health experts worry that the administration is not being aggressive enough in waging what the president calls a “wartime effort” to vaccinate the […]
The move brings the total number of Johnson & Johnson doses made at the troubled plant and cleared by the F.D.A. to roughly 40 million.
The move brings the total number of Johnson & Johnson doses made at the troubled plant and cleared by the F.D.A. to roughly 40 million.
The move brings the total number of Johnson & Johnson doses made at the troubled plant and cleared by the F.D.A. to roughly 40 million.
The Pfizer and Moderna vaccines are safe and effective. Full approval from the F.D.A. will help stop the spread of Covid-19.
The Pfizer and Moderna vaccines are safe and effective. Full approval from the F.D.A. will help stop the spread of Covid-19.
The Pfizer and Moderna vaccines are safe and effective. Full approval from the F.D.A. will help stop the spread of Covid-19.
Even those who supported the F.D.A.’s approval of the controversial new drug said authorizing it for anyone with Alzheimer’s disease was much too broad.
The agency has not decided whether to allow a troubled vaccine factory in Baltimore to reopen.
The F.D.A.’s approval of the Alzheimer’s drug aducanumab is inexplicable.
The F.D.A.’s approval of the Alzheimer’s drug aducanumab is inexplicable.
With the pandemic easing, the federal agency’s long-term agenda for drug approvals or new issues is languishing without a permanent commissioner.
With the pandemic easing, the federal agency’s long-term agenda for drug approvals or new issues is languishing without a permanent commissioner.
The agency has not decided whether to allow a troubled vaccine factory in Baltimore to reopen.
The pharmacist, Steven R. Brandenburg, believed in conspiracy theories and thought vaccines were dangerous, the authorities said.
The pharmacist, Steven R. Brandenburg, believed in conspiracy theories and thought vaccines were dangerous, the authorities said.
Aducanumab, or Aduhelm, is the first new Alzheimer’s treatment in 18 years and the first to attack the disease process. But some experts say there’s […]
Aducanumab, or Aduhelm, is the first new Alzheimer’s treatment in 18 years and the first to attack the disease process. But some prominent experts say […]
Aducanumab is the first new Alzheimer’s treatment in 18 years and the first to attack the disease process. But some prominent experts say there’s not […]
If the agency approves it, aducanumab would be the first new Alzheimer’s treatment since 2003. Patients are desperate for new options, but some scientists say […]
If the agency approves it, aducanumab would be the first new Alzheimer’s treatment since 2003. Patients are desperate for new options, but some scientists say […]
If the agency approves it, aducanumab would be the first new Alzheimer’s treatment since 2003. Patients are desperate for new options, but some scientists say […]
Regulators allowed a new antifungal treatment, but critics say it is unneeded and costs too much.
Regulators allowed a new antifungal treatment, but critics say it is unneeded and costs too much.
Regulators OK’d a new antifungal treatment, but critics say it is unneeded and costs too much.
Regulators OK’d a new antifungal treatment, but critics say it is unneeded and costs too much.
The company’s application follows the move by Pfizer and BioNTech to seek full approval last month. The vaccines already have emergency use authorization in the […]
The company’s application follows the move by Pfizer and BioNTech to seek full approval last month. The vaccines already have emergency use authorization in the […]
The company’s application follows the move by Pfizer and BioNTech to seek full approval last month. The vaccines already have emergency use authorization in the […]
The company’s application follows the move by Pfizer and BioNTech to seek full approval last month. The vaccines already have emergency use authorization in the […]
The drug, from GlaxoSmithKline and Vir, aims to keep those who have contracted the disease out of the hospital.
The drug, from GlaxoSmithKline and Vir, aims to keep those who have contracted the disease out of the hospital.
The drug, from GlaxoSmithKline and Vir, aims to keep those who have contracted the disease out of the hospital.
The drug, from GlaxoSmithKline and Vir, aims to keep Covid patients out of the hospital.
The Big Pharma drug model is inefficient and unsustainable. There is an alternative.
The Big Pharma drug model is inefficient and unsustainable. There is an alternative.
La esperanza es que los nuevos tratamientos animen a la gente a considerar la obesidad como una condición crónica, como la hipertensión o la diabetes.
La esperanza es que los nuevos tratamientos animen a la gente a considerar la obesidad como una condición crónica, como la hipertensión o la diabetes.
La esperanza es que los nuevos tratamientos animen a la gente a considerar la obesidad como una condición crónica, como la hipertensión o la diabetes.
La esperanza es que los nuevos tratamientos animen a la gente a considerar la obesidad como una condición crónica, como la hipertensión o la diabetes.
The hope is that new treatments will encourage people to think of obesity as a chronic disease, like high blood pressure or diabetes.
The hope is that new treatments will encourage people to think of obesity as a chronic disease, like high blood pressure or diabetes.
The hope is that new treatments will encourage people to think of obesity as a chronic disease, like high blood pressure or diabetes.
The company said it also plans to apply this month for full F.D.A. approval — not just emergency authorization — for the vaccine’s use in […]
The company said it also plans to apply this month for full F.D.A. approval — not just emergency authorization — for the vaccine’s use in […]
The U.S. vaccination campaign will soon expand to millions more people, but public health experts say the move raises complicated questions about supply and access.
The U.S. vaccination campaign will soon expand to millions more people, but public health experts say the move raises complicated questions about supply and access.
The company said it also plans to apply this month for full F.D.A. approval — not just emergency authorization — for the vaccine’s use in […]
The U.S. vaccination campaign will soon expand to millions more people, but public health experts say the move raises complicated questions about supply and access.
We asked eight people from around the world what they thought about American health care. It didn’t go well.
We asked eight people from around the world what they thought about American health care. It didn’t go well.
President Biden will send up to 60 million doses of AstraZeneca’s vaccine to countries pleading for help, but some see a medicine dropper for “a […]
We asked eight people from around the world what they thought about American health care. It didn’t go well.
President Biden will send up to 60 million doses of AstraZeneca’s vaccine to countries pleading for help, but some see a medicine dropper for “a […]
Last month, up to 15 million doses of Johnson & Johnson’s vaccine had to be discarded at Emergent’s factory in Baltimore. A new report says […]
Last month, up to 15 million doses of Johnson & Johnson’s vaccine had to be discarded at Emergent’s factory in Baltimore. A new report says […]
The agency said it would stop enforcing a rule requiring women to get the first of two pills in person at a medical clinic or […]
The agency said it would stop enforcing a rule requiring women to get the first of two pills in person at a medical clinic or […]
Johnson & Johnson’s single-dose Covid-19 shots were halted across the United States on Tuesday after federal health agencies called for a pause in their use […]
Johnson & Johnson’s single-dose Covid-19 shots were halted across the United States on Tuesday after federal health agencies called for a pause in their use […]
Federal health agencies made the decision to halt the use of the Johnson and Johnson vaccine after six women between the ages of 18 and […]
The agency said it would stop enforcing a rule requiring women to get the first of two pills in person at a medical clinic or […]
I’ve reported on behavior and mental health for 20 years. As I exit, I can’t help but wonder why researchers have placed so little emphasis […]
I’ve reported on behavior and mental health for 20 years. As I exit, I can’t help but wonder why researchers have placed so little emphasis […]
I’ve reported on behavior and mental health for 20 years. As I exit, I can’t help but wonder why researchers have placed so little emphasis […]
According to federal officials, an independent panel of medical experts said the promising results announced by the company on Monday may have relied on “outdated […]
The company is preparing to apply for emergency authorization from the Food and Drug Administration. But the shot may not be needed in the United […]
The company is preparing to apply for emergency authorization from the Food and Drug Administration. But the shot may not be needed in the United […]
The company is preparing to apply for emergency authorization from the Food and Drug Administration. But the shot may not be needed in the United […]
The company is preparing to apply for emergency authorization from the Food and Drug Administration. But the shot may not be needed in the United […]
The company is preparing to apply for emergency authorization from the Food and Drug Administration. But the shot may not be needed in the United […]
The company is preparing to apply for emergency authorization from the Food and Drug Administration. But the shot may not be needed in the United […]
Randomized, evidence-based trials, long required for new drugs, are now underway for government policy initiatives.
Randomized, evidence-based trials, long required for new drugs, are now underway for government policy initiatives.
Randomized, evidence-based trials, long required for new drugs, are now underway for government policy initiatives.
Randomized, evidence-based trials, long required for new drugs, are now underway for government policy initiatives.
Randomized, evidence-based trials, long required for new drugs, are now underway for government policy initiatives.
Randomized, evidence-based trials, long required for new drugs, are now underway for government policy initiatives.
Randomized, evidence-based trials, long required for new drugs, are now underway for government policy initiatives.
He was the first hospital official to question the use of an unregulated vitamin injection linked to the deaths of 38 infants. He died of […]
He was the first hospital official to question the use of an unregulated vitamin injection linked to the deaths of 38 infants. He died of […]
He was the first hospital official to question the use of an unregulated vitamin injection linked to the deaths of 38 infants. He died of […]
The steep decline in oversight has stalled a number of new drug applications. The agency says it is trying to protect its employees but critics […]
The steep decline in oversight has stalled a number of new drug applications. The agency says it is trying to protect its employees but critics […]
Johnson & Johnson’s one-shot vaccine is allowing states to rethink distribution, even as health officials and experts worry some will view it as inferior.
As President Biden accelerates plans for manufacturing vaccines and several states move to reopen, we check in on the virus.
As President Biden accelerates plans for manufacturing vaccines and several states move to reopen, we check in on the virus.
As President Biden accelerates plans for manufacturing vaccines and several states move to reopen, we check in on the virus.
The pharmaceutical giant Merck & Co. agreed to help manufacture Johnson & Johnson’s coronavirus vaccine, in a deal partly brokered by the White House.
Two leading contenders generate wider debate about the leadership needed to restore morale and scientific integrity to an agency battered by the politicized Trump administration.
Two leading contenders generate wider debate about the leadership needed to restore morale and scientific integrity to an agency battered by the politicized Trump administration.
Two leading contenders generate wider debate about the leadership needed to restore morale and scientific integrity to an agency battered by the politicized Trump administration.
Two leading contenders generate wider debate about the leadership needed to restore morale and scientific integrity to an agency battered by the politicized Trump administration.
Two leading contenders generate wider debate about the leadership needed to restore morale and scientific integrity to an agency battered by the politicized Trump administration.
Two leading contenders generate wider debate about the leadership needed to restore morale and scientific integrity to an agency battered by the politicized Trump administration.
Federal regulators are in favor of a simple, potentially quick fix to bolster coronavirus vaccine supplies: more doses per bottle.
Federal regulators are in favor of a simple, potentially quick fix to bolster coronavirus vaccine supplies: more doses per bottle.
Federal regulators are in favor of a simple, potentially quick fix to bolster coronavirus vaccine supplies: more doses per bottle.
Federal regulators are in favor of a simple, potentially quick fix to bolster coronavirus vaccine supplies: more doses per bottle.
Federal regulators are in favor of a simple, potentially quick fix to bolster coronavirus vaccine supplies: more doses per bottle.
Federal regulators are in favor of a simple, potentially quick fix to bolster coronavirus vaccine supplies: more doses per bottle.
Federal regulators are in favor a simple, potentially quick fix to bolster coronavirus vaccine supplies: more doses per bottle.
The company will ask federal regulators to increase the amount of coronavirus vaccine it can put in each vial by as much as 50 percent, […]
President Biden said the amount of coronavirus vaccines reaching the states would rise next week and a deal was near to provide enough shots to […]
President Biden said the number of coronavirus vaccines reaching the states would rise next week and a deal was near to provide enough shots to […]
President Biden said the number of coronavirus vaccines reaching the states would rise next week and a deal was near to provide enough shots to […]
President Biden said the number of coronavirus vaccines reaching the states would rise next week and a deal was near to provide enough shots to […]
A combination of two injectable drugs will provide an alternative to daily pills for people with H.I.V.
A combination of two injectable drugs will provide an alternative to daily pills for people with H.I.V.
A combination of two injectable drugs will provide an alternative to daily pills for people with H.I.V.
A combination of two injectable drugs will provide an alternative to daily pills for people with H.I.V.
A combination of two injectable drugs will provide an alternative to daily pills for people with H.I.V.
A combination of two injectable drugs will provide an alternative to daily pills for people with H.I.V.
Dr. David Kessler, who helped speed the development and approval of AIDS drugs in the 1990s, will become the top science official for the initiative […]
Dr. David Kessler, who helped speed the development and approval of AIDS drugs in the 1990s, will become the top science official for the initiative […]
Dr. David Kessler, who helped speed the development and approval of AIDS drugs in the 1990s, will become the top science official for the initiative […]
Dr. David Kessler, who helped speed the development and approval of AIDS drugs in the 1990s, will become the top science official for the initiative […]
Dr. David Kessler, who helped speed the development and approval of AIDS drugs in the 1990s, will become the top science official for the initiative […]
Dr. David Kessler, who helped speed the development and approval of AIDS drugs in the 1990s, will become the top science official for the initiative […]
Dr. David Kessler, who helped speed the development and approval of AIDS drugs in the 1990s, will become the top science official at Operation Warp […]
Here’s information about who these therapies can help, how much they cost and how to find out if you can get them where you live.
Here’s information about who these therapies can help, how much they cost and how to find out if you can get them where you live.
Here’s information about who these therapies can help, how much they cost and how to find out if you can get them where you live.
The company’s vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which […]
The Food and Drug Administration authorized a second coronavirus vaccine for emergency use, clearing the way for millions more Americans to be immunized next week.
An advisory group’s recommendation will mean millions more Americans can be inoculated, extending protection against Covid beyond big urban areas into rural and suburban regions.
La revisión positiva probablemente asegure que la Administración de Alimentos y Medicamentos (FDA, por su sigla en inglés) concederá esta semana la autorización de emergencia […]
La revisión positiva probablemente asegure que la Administración de Alimentos y Medicamentos (FDA, por su sigla en inglés) concederá esta semana la autorización de emergencia […]
The Trump administration is discussing helping the drug maker get the raw materials it would need to produce tens of millions of extra doses of […]
La revisión positiva probablemente asegure que la Administración de Alimentos y Medicamentos (FDA, por su sigla en inglés) concederá esta semana la autorización de emergencia […]
The positive review likely ensures that the F.D.A. will approve a second coronavirus vaccine this week for millions of Americans.
British health officials recommended that people with severe allergy reactions not be given the vaccine. Such reactions to vaccines are rare, even in people who […]
An advisory panel of the Food and Drug Administration recommended authorization of the Pfizer-BioNTech coronavirus vaccine. The F.D.A. is expected to make its formal announcement […]
An advisory panel of the Food and Drug Administration recommended authorization of the Pfizer-BioNTech coronavirus vaccine. The F.D.A. is expected to make its formal announcement […]
An advisory panel of the Food and Drug Administration recommended authorization of the Pfizer-BioNTech coronavirus vaccine. The F.D.A. is expected to make its formal announcement […]
The Oxford-AstraZeneca effort held great promise to help arrest the pandemic. But a series of miscues caused it to fall behind in the U.S.
If approved, the first batch of vaccine could arrive in the state on Dec. 15, the governor said, and contain enough doses for 170,000 people.
Marketed as “missed-period pills,” abortion drugs administered as early as 28 days after a woman’s last period can offer comfort in uncertainty to those who […]
The company said the trial would involve children ages 12 through 17.
Science and objective analysis need to be revived.
For the 80,000 children who die of H.I.V. each year, drugs are often bitter or hard to swallow. Dolutegravir will soon come in a tasty […]
The first shots could be given as early as Dec. 21, if authorization is granted.
Court filings reveal consultants’ talk of a records purge during the opioid crisis, and shed new light on sales advice given to the billionaire Sackler […]
A large team of regulators at the agency will take about three weeks to review an application spanning thousands of pages.
The treatment, made by the biotech company Regeneron, is a cocktail of two powerful antibodies that have shown promise for people who get it early […]
The news sent the stock market soaring as it represents a key milestone in developing and distributing a vaccine for the virus. Still public confidence […]
The guidance calls for a median two months’ worth of follow-up safety data from well-designed Phase III studies as a precondition for a vaccine receiving […]
Reuters reported Wednesday that U.S. regulators would look at data from previous clinical trials that came from the same scientists who created the vaccine, AZD1222, […]
The FDA commissioner took to Twitter Monday night to defend his performance at the agency, which came under sharp criticism amid accusations that the authorization […]
While the emergency use authorization granted Sunday was not seen as scientifically unwarranted, it drew concerns from some experts that it could hinder enrollment in […]
Over the weekend, Trump called the agency, without evidence, part of a “deep state” that was slow-walking vaccines and drugs for Covid-19. The next day, […]
The New York Times reported that the FDA was prepared to issue an emergency use authorization for the treatment last week, but NIH Director Francis […]
In a CRL issued for valoctocogene roxaparvovec, the FDA told BioMarin that differences between its Phase I/II and Phase III studies limited the ability to […]
While there had been some risks to filgotinib’s approval cited before, analysts expressed surprise at the decision, with one writing it would likely delay approval […]
The agency approved Enspryng for the disease, which is often misdiagnosed as multiple sclerosis and can cause blindness, muscle weakness and paralysis.
Three of the companies making drugs used in the Phase II I-SPY COVID-19 study – Amgen, AbbVie and Takeda – announced the patient enrollments Monday. […]
Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning […]
The patient, who had been enrolled in the Phase I study at the higher dose level of UCARTCS1A, suffered a cardiac arrest, the causes of […]
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