In another blow to FDAs institutional knowledge, CBER deputy director Celia M. Witten leaves the agency amid a deepening staff exodus and plunging mor...
FDA says semaglutide injection product shortages (Novo Nordisks Wegovy and Ozempic) are resolved.
Pfizer discontinues the marketing of its hemophilia B gene therapy Beqvez (fidanacogene elaparvovec-dzkt) due to limited patient and physician interes...
FDA accepts for priority review a Boehringer Ingelheim NDA for zongertinib (BI 1810631) for treating certain adult patients with unresectable or metas...
FDA staff tell Reuters a potentially bogus list of words that cant be used in external communications under a Trump Executive Order includes woman, di...
The Texas federal judge hearing the consolidated cases against FDA over its final rule on laboratory-developed tests promises a ruling as soon as poss...
Sens. Charles Grassley and Amy Klobuchar reintroduce legislation to provide for safe importation of drugs from Canada.
FDA clears an Ezra 510(k) for its Ezra Flash AI model for MRI imaging.
