FDA delays by three months its decision on Eisai and Biogen's subcutaneous starting-dose formulation of Alzheimers drug Leqembi (lecanemab) after the ...
A legal analysis published by Crowell & Moring says a proposed FDA pilot program on artificial intelligence in early-stage clinical trials could shape...
President Trump tells reporters he knows nothing about reports suggesting FDA commissioner Marty Makary will be asked to resign soon.
FDA posts new technical guidance document outlining how sponsors should submit continuous glucose monitoring data collected during clinical trials for...
Boston Scientific begins a Class 1 recall (device correction) involving certain pacemakers and cardiac resynchronization therapy pacemakers following ...
Several media outlets report that President Trump has signed off on a plan to remove FDA commissioner Marty Makary from his post.
FDA approves a Partner Therapeutics BLA for Bizengri (zenocutuzumab-zbco) for adults with advanced, unresectable or metastatic cholangiocarcinoma harb...
Atara Biotherapeutics says it and partner Pierre Fabre Pharmaceuticals have received feedback from FDA outlining a potential path toward resubmitting ...
