FDA warns Indias Glenmark Pharmaceuticals about CGMP violations in the production of finished drugs at one of its manufacturing facilities.
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...
FDA names Stanford pediatrics adjunct professor George Tidmarsh, an industry veteran for over 30 years, as the new CDER director.
Integra LifeSciences recalls (Class 1) its MicroMyst Applicators due to incomplete bioburden assessments and incomplete sterilization location transfe...
Sarepta brushes off an informal request from FDA to voluntarily halt shipment of Elevidys (delandistrogene moxeparvovec), a gene therapy for Duchenne ...
