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FDA rejects an Invivyd request to expand the existing emergency use authorization for pre-exposure prophylaxis of Covid-19 EUA for...[ Price : $8.95]
FDA approves a Mirum Pharmaceuticals NDA for Ctexli (chenodiol) for treating adults with cerebrotendinous xanthomatosis.[ Price : $8.95]
Pharmaceutical Research and Manufacturers of America says FDA should revise its recommendations for sponsors requesting meetings c...[ Price : $8.95]
In another blow to FDAs institutional knowledge, CBER deputy director Celia M. Witten leaves the agency amid a deepening staff exo...[ Price : $8.95]
FDA says semaglutide injection product shortages (Novo Nordisks Wegovy and Ozempic) are resolved.[ Price : $8.95]
Pfizer discontinues the marketing of its hemophilia B gene therapy Beqvez (fidanacogene elaparvovec-dzkt) due to limited patient a...[ Price : $8.95]
FDA accepts for priority review a Boehringer Ingelheim NDA for zongertinib (BI 1810631) for treating certain adult patients with u...[ Price : $8.95]
Three Arnall Golden Gregory attorneys describe steps foreign drug and medical device companies can take to prepare for what they s...