In briefing documents released ahead of an Advisory Committee meeting this week, FDA staffers cited safety risks related to a ...

A new opioid threat you probably haven't heard about is targeting kids. Products containing 7-OH are currently being sold ...

The FDA’s top vaccine and gene therapy official resigned amid heightened scrutiny over recent drug approval decisions and ...

On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...

Dozens of lawmakers are urging U.S. health regulators to crack down on the booming market for knockoff weight-loss drugs amid ...

But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...

Food and Drug Administrator Commissioner Marty Makary has requested that the Drug Enforcement Administration classify 7-OH as ...

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

Powerful new medications such as Ozempic and Mounjaro, known as GLP-1 drugs are helping to win the war against obesity in ...

Commissioner Marty Makary said in an interview with Politico’s Dasha Burns that the FDA will “look at the data” surrounding ...

Experts on the panel shared many of the same views around SSRIs, arguing the risks of the drugs during pregnancy are greater ...

Class II recalls from the FDA indicate a potential risk to consumer safety where use or exposure to the product may cause ...