FDA

News

There is enough experience with the first wave of autologous CAR-T therapies to allow strict rules ensuring their safe use to be relaxed, says FDA.

R&D

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."