Zachary Brennan

Leadership in the FDA's Office of New Drugs sent an email to staff Friday afternoon asking if anyone would volunteer to take on more administrative work, following the firing of many of the agency's administrators and project managers last month.

Several members of an FDA advisory committee warned on Monday that new data from studies on long-term use of opioids might underestimate the harms from their misuse and abuse.

Capricor Therapeutics' cell therapy for Duchenne muscular dystrophy will face an FDA advisory committee ahead of an approval decision that's expected Aug. 31, the company disclosed on Monday.

House and Senate lawmakers from both parties are working with the Trump administration on proposals that would use drug prices paid by other developed countries as a reference for the US.

Marty Makary named Vinay Prasad as the next director of the Center for Biologics and Research, Endpoints News has learned.

The FDA announced a two-day meeting of its Oncologic Drugs Advisory Committee (ODAC) later this month to review cancer drugs from Genentech, Pfizer, J&J and UroGen.

Vinay Prasad may have just started as the new director of the FDA's biologics center, but he's 'planning to unleash a massive framework' on vaccines in the 'coming days,' FDA Commissioner Marty Makary said Thursday.

The FDA is prepping to renegotiate its multibillion-dollar, quinquennial user fee agreements with the drug industry later this summer, and a new deputy commissioner on Friday suggested the structure of the deal may need to be reworked.

Genentech, J&J, UroGen and Pfizer will all come before ODAC, with Oncology Center of Excellence chief Richard Pazdur in attendance.

The FDA's Oncologic Drugs Advisory Committee voted 8 to 1 against whether Genentech's pivotal trial is applicable to the US patient population for a Columvi label expansion.