FDA

FDA
MedTech

FDA formally kicks off medical device user fee negotiations

The FDA formally kicked off its quinquennial process to reauthorize the federal user fee legislation that helps fund its medical device reviews.
Conor Hale Aug 4, 2025 4:45pm
Monoclonal antibody orange red background 3d rendering

Allogene reports patient death tied to mAb in CAR-T pivotal trial

Aug 1, 2025 8:30am
Graphic of a fork in the road with arrows pointing in either direction
Favicon Fierce Pharma

Prasad exit signals more permissive FDA for cell and gene field

Jul 31, 2025 9:10am
target reach ladder climb meet win beat competition
Favicon Fierce Pharma

FDA taps new CDER chief as acting CBER head after Prasad exit

Jul 30, 2025 1:10pm
Cardiosense CardioTag device

Cardiosense scores FDA clearance for wearable cardiac monitor

Jul 30, 2025 11:30am
delay

FDA delays hit clinical trial launch decisions

Jul 30, 2025 10:29am