FDA rejects a Replimune priority-reviewed BLA for its melanoma therapy RP1 (vusolimogene oderparepvec).
FDA wins the latest round in its regulatory battle against gene therapy maker Sarepta Therapeutics after the company agrees to stop shipping Duchenne ...
Center for Medicine in the Public Interest president Peter Pitts says FDA must protect patients by tightening its regulation of compounding pharmacies...
Conspiracy theorist and Trump confidant Laura Loomer urges the firing of CBER director Vinay Prasad due to his previous anti-Trump rhetoric and lifelo...
Responding to congressional Democrats, the Congressional Budget Office says a nine-month increase in FDA drug review times would lead to fewer drugs b...
FDA issues an early alert highlighting serious safety concerns with Baxter's Novum IQ large volume infusion pump.
FDA researchers analyze the results of good clinical practice inspections from 2017 to 2023, finding that less than 1% resulted in an official action ...
Johnson & Johnson files an NDA for icotrokinra, which it describes as a first-in-class oral therapy for moderate to severe plaque psoriasis.
