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.
Testing found nitrosamine contamination in some samples of Januvia, but regulators will allow Merck to continue selling the drug for now.
The agency’s commissioner asked an external foundation to examine its operations in the wake of the baby formula and vaping crises.
The most urgent step the federal government can take is to ensure access to medication abortion.
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 […]
It needs to promote innovation, not reward legal trickery.
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 […]
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 […]
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 […]
Dr. Robert Califf, a former agency commissioner, is encountering opposition over federal opioid and abortion policies and his industry ties.
A split committee vote revealed concerns about the opioid epidemic and abortion policies, foreshadowing a likely close vote on confirmation by the full Senate.
A split committee vote revealed concerns about the opioid epidemic and abortion policies, foreshadowing a likely close vote on confirmation by the full Senate.
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 […]
A Senate panel hearing on Tuesday signaled that Dr. Robert Califf, who briefly led the agency during the Obama administration, had some bipartisan support.
A Senate panel hearing on Tuesday signaled that Dr. Robert Califf, who briefly led the agency during the Obama administration, had some bipartisan support.
A Senate panel hearing on Tuesday signaled that Dr. Robert Califf, who briefly led the agency during the Obama administration, had some bipartisan support.
A Senate panel hearing on Tuesday signaled that Dr. Robert Califf, who briefly led the agency during the Obama administration, had some bipartisan support.
The treatment, Paxlovid, is the second antiviral pill to show effectiveness in treating Covid.
. The request is for use in unvaccinated, high risk patients. But the regulator could authorize it for broader use.
. The request is for use in unvaccinated, high risk patients. But the regulator could authorize it for broader use.
Regulators are set to clear extra doses of Pfizer-BioNTech’s vaccine as soon as Thursday, after states began expanding eligibility on their own.
. The request is for use in unvaccinated, high risk patients. But the regulator could authorize it for broader use.
The treatment, Paxlovid, is the second antiviral pill to show effectiveness in treating Covid, and works differently from the first.
Dr. Robert M. Califf, an academic and clinical trial researcher who ran the agency in 2016, has also consulted for pharmaceutical companies.
Dr. Robert M. Califf, an academic and clinical trial researcher who ran the agency in 2016, has also consulted for pharmaceutical companies.
Dr. Robert M. Califf, an academic and clinical trial researcher who ran the agency in 2016, has also consulted for pharmaceutical companies.
Dr. Robert M. Califf, an academic and clinical trial researcher who ran the agency in 2016, has also consulted for pharmaceutical companies.
Experts say recent compromises could create less harm in balancing innovation with profits.
Experts say recent compromises could create less harm in balancing innovation with profits.
Experts say recent compromises could create less harm in balancing innovation with profits.
Experts say recent compromises could create less harm in balancing innovation with profits.
Experts say recent compromises could create less harm in balancing innovation with profits.
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 […]
The agency may act this week, when it is expected to authorize booster shots for recipients of the Moderna and Johnson & Johnson vaccines.
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 […]
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 […]
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 […]
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 […]
The experts’ recommendations, though not binding, are likely to influence what the Food and Drug Administration decides on whether to authorize the boosters.
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 […]
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.
The request, expected this week, comes after a study found the company’s vaccine was only 71 percent effective against hospitalization from Covid-19.
The request, expected this week, comes after a study found the company’s vaccine was only 71 percent effective against hospitalization from Covid-19.
At least 21 percent of nursing home residents are on antipsychotic drugs, a Times investigation found.
At least 21 percent of nursing home residents are on antipsychotic drugs, a Times investigation found.
The agency that regulates drug safety has become too cozy with the industry it’s supposed to oversee.
The agency that regulates drug safety has become too cozy with the industry it’s supposed to oversee.
The agency that regulates drug safety has become too cozy with the industry it’s supposed to oversee.
Emergent BioSolutions, which ruined 75 million vaccine doses at its Baltimore plant, disclosed records requests from Congress and federal and state law enforcement agencies.
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.
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.
An order reflects the administration’s growing embrace of warnings by some economists that declining competition is hobbling the economy’s vitality.
An order reflects the administration’s growing embrace of warnings by some economists that declining competition is hobbling the economy’s vitality.
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 agency has not decided whether to allow a troubled vaccine factory in Baltimore to reopen.
Production problems and a brief pause on its use kept the one-dose vaccine from becoming the game changer that health officials across the country believed […]
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 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 […]
An inoculation push, plagued with limited supplies and red tape, makes doses available to those who can pay for them. In a country with a […]
An inoculation push, plagued with limited supplies and red tape, makes doses available to those who can pay for them. In a country with a […]
An inoculation push, plagued with limited supplies and red tape, makes doses available to those who can pay for them. In a country with a […]
Emergent BioSolutions’ C.E.O. announced several executive changes but vigorously defended the company, which is on track for record revenues.
Emergent BioSolutions’ C.E.O. announced several executive changes but vigorously defended the company, which is on track for record revenues.
Emergent BioSolutions’ C.E.O. announced several executive changes but vigorously defended the company, which is on track for record revenues.
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.
We asked eight people around the world what they thought. It didn’t go well.
We asked eight people around the world what they thought. It didn’t go well.
We asked eight people around the world what they thought. 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.
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, […]
A large team of regulators at the agency will take about three weeks to review an application spanning thousands of pages.
A new rule would base the price Medicare pays for certain drugs on the lowest price paid among similar countries. But a rushed process means […]
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