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...
Three Arnall Golden Gregory attorneys describe steps foreign drug and medical device companies can take to prepare for what they see as a likely incre...
HHS appoints Robert Fox Foster as FDAs next chief counsel.
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.
