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.
FDA clears a Median Technologies 510(k) for eyonis LCS, the first artificial intelligencebased device cleared for both detection and diagnosis in lung...
FDA drug regulators and pharmaceutical industry representatives reach a partial agreement on drug development tools, including biomarker qualification...
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The Biotechnology Innovation Organization urges FDA to broaden application of its draft guidance on Monoclonal Antibodies: Streamlined Nonclinical Saf...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 approves a Kite Oncology labeling update for CAR-T therapy Yescarta (axicabtagene ciloleucel), removing a previous limitation on its use in patien...
