FDA warns Mark Dacey of Denver, CO, about failing to obtain informed consent for two clinical investigations he conducted.
Faced with increasing FDA scrutiny and litigation threats from Novo Nordisk, Hims & Hers abruptly shelves its GLP 1 weight loss pill offering.
The Biotechnology Innovation Organization urges FDA to broaden application of its draft guidance on Monoclonal Antibodies: Streamlined Nonclinical Saf...
FDA issues two untitled letters to Argenx, alleging that separate direct-to-consumer television advertisements for Vyvgart Hytrulo overstate benefits,...
Aurobindo Pharma says that FDA has completed an inspection of wholly owned subsidiary Eugia Pharma Specialities in Pashamylaram, Telangana, India that...
FDA tells Novo Nordisk that a new direct-to-consumer television ad for the newly launched Wegovy (semaglutide) oral weight-loss pill contains claims t...
FDA issues Regenxbio a complete response letter on its BLA seeking accelerated approval for RGX-121 (clemidsogene lanparvovec), a one-time gene therap...
The Alliance for Pharmacy Compounding petitions FDA asking that it reverse its classification of desiccated thyroid extract as a biologic product.
