In a year that saw advisory committees placed under a particularly bright microscope at the FDA, the agency held fewer ...

“What’s that? (I may be paranoid, but no android),” Radiohead once sang. That familiar tension between human judgment and technology echoes strong in today’s debate about artificial intelligence (“AI” ...

On November 6, 2025, the U.S. Food and Drug Administration's (FDA) Digital Health Advisory Committee (DHAC) convened for the second time since its inception to explore the regulatory pathways, ...

Pitts, a former FDA associate commissioner, was the agency’s senior official in charge of advisory committees. During my time at the Food and Drug Administration, I was the senior official in charge ...

FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency’s decisions from ...

On Tuesday, a U.S. Food and Drug Administration advisory committee voted unanimously that the oral formulation of a very common nasal decongestant, phenylephrine, is not effective. The decision could ...

Capricor Therapeutics saw its shares fall 13% by the end of trading Monday as its investigational cell therapy deramiocel for DMD was revealed as the first drug expected to face an FDA advisory ...

UroGen Announces FDA Advisory Committee for UGN-102, an Investigational Treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer UroGen (NASDAQ: URGN), a biotech company ...