FDA

News

The FDA says it will review clinical trials that send US citizens' cells to 'hostile countries' as the agency's leadership in this area is sidelined.

News

FDA Commissioner Marty Makary has revealed a new priority review voucher programme for new medicines deemed to be of national priority for the US.

Market Access

FDA Commissioner Dr Martin Makary took the stage at BIO 2025 to detail the way he and his team have been challenging “deeply held assumptions”.

News

Top FDA officials have spelled out their strategic priorities in the coming years, including the use of AI to "increase efficiency."

News

The FDA has rolled out its highly-touted generative AI tool, almost a month early, with a promise to reduce the time taken for regulatory reviews.

News

Stealth BioTherapeutics' filing for Barth syndrome therapy elamipretide has been turned down by the FDA, but there may be a way forward for the drug.