46 new molecular entities cleared the agency’s hurdles last year, 4 fewer than in 2024 ...

The Food and Drug Administration (FDA) defied the advice of its own drug safety experts to warn pregnant women about Tylenol for nearly a decade, internal reports and presentations obtained by the ...

The US saw several new and expanded FDA indications this year. The top 5 most-read FDA approvals on AJMC.com included 4 novel ...

Stream NBC 5 for free, 24/7, wherever you are. The Food and Drug Administration will consider drug affordability when granting companies new vouchers that speed up approvals of some treatments, the ...

Dr Reshma Ramachandran of Yale University noted that FDA leaders are now meeting with drug company CEOs behind closed doors in six cities, The Times said in a new report. HealthDay News — The US Food ...

The Food and Drug Administration said it will take steps to speed up the process of developing generic versions of complex biological drugs, in a bid to increase cheaper competition for expensive ...

For many people, the end of the year is a mad rush to wrap things up before the holidays, and so it was for the FDA. Notable regulatory decisions include the first drug approval for a prevalent ...

Dec 23 () - The weight-loss drug market is surging, with biotech firms racing to win share in a sector dominated by Novo Nordisk and Eli Lilly. Analysts forecast the industry will generate about $150 ...

The U.S. Food and Drug Administration (FDA) on Thursday announced an expedited plan to implement artificial intelligence (AI) across all FDA centers by June 30 in a bid to speed up the review process ...

FDA approvals in 2025 introduced novel therapies and devices across ophthalmic subspecialties, emphasizing sustained efficacy ...

The U.S. Food and Drug Agency is not really a singular agency. In practice, it operates more like five or more “FDAs” — each covering drugs, devices, food, cosmetics, or tobacco — combined into one. A ...