Zachary Brennan

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.

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 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.

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.

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.

The FDA on Friday said it's pulling two final guidance documents published earlier this year that sought to help entities manufacturing cell- and tissue-based medical products to make better donor eligibility determinations.

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.

FDA Commissioner Marty Makary announces plans for new conditional approval pathway for rare disease drugs, discusses agency reforms in SiriusXM interview with Megyn Kelly.

The FDA is looking to further limit pharma companies' involvement in advisory committees that typically review new drugs or safety issues. But the shift away from pharma influence is likely to have little impact on committee discussions.

100+ biotech & VC execs write to Sen. Cassidy about FDA staffing concerns, citing delays & uncertainties due to loss of experienced staff & hiring freeze

The nonprofit drug pricing watchdog Institute for Clinical and Economic Review on Wednesday released a new report outlining potential federal policy solutions to increase access to blockbuster obesity drugs known as GLP-1s.

New FDA Commissioner Marty Makary took to the stage at the agency's Maryland headquarters on Wednesday, in his first public communication to much of the agency since Tuesday's mass firings.

FDA faces leadership crisis as Peter Marks and other senior officials exit amid tensions with HHS Secretary Robert F. Kennedy Jr. over vaccine policies. New Commissioner Makary's role unclear.

HHS’ plans to eliminate almost 20% of the FDA’s staff will likely take a major toll on policy, communications and other administrative staff at the agency, according to agency veterans and other sources.

New research published by FDA authors found that 67% of non-oncologic rare disease marketing applications approved between 2020 and 2023 used only one clinical trial plus confirmatory evidence to demonstrate effectiveness.

Packed parking, long security lines and traffic greeted returning FDA workers on Monday, who were called back to the agency's main White Oak campus as part of the Trump administration's effort to force federal employees back to in-office work.

DOGE says that it has terminated the leases of 30 FDA offices and buildings, including a 52,000 square-foot St. Louis-based lab that operates under the FDA's Office of Pharmaceutical Quality.