Finding
FDA delays PDUFA date for small biotech, raising questions about impact of agency cuts
United States Food and Drug Administration, PDUFA, Impact food supplement, Approved, Agencies, questions
FDA chief Makary talks expediting drug approvals, RIFs and the abortion pill
United States Food and Drug Administration, Califf, Unspecified Abortion, Contraceptives, Oral, Accelerated, Artificial Intelligence, RIFs, Infrequent, Agencies
Novo Nordisk taps telehealth giants to distribute Wegovy, sending shares soaring
Wegovy, Nordisk, LifeMD, Telemedicine, Access, CALR gene, Obesity, semaglutide, Adult
Pfizer’s Bourla is ‘cautiously optimistic’ on tariffs, says M&A is on the table
Bourla, M&A, Pfizer, United States, TNFRSF19 gene, Policy, tariffs
AbbVie’s Rinvoq cleared for giant cell arteritis in US
Giant Cell Arteritis, Rinvoq, upadacitinib, Approved, Janus kinase, Inhibitor, United States Food and Drug Administration, Steroids
Keytruda around head and neck cancer surgery cuts chance of disease coming back
Keytruda, Head, perioperative, Episodic
J&J reports durability data for bladder cancer ‘pretzel’ drug after FDA filing
Urinary Bladder, TAR 200, United States Food and Drug Administration, Malignant neoplasm of urinary bladder
Gilead, ‘closely attuned to’ potential US policy shifts, stands by long-acting PrEP launch
Lenacapavir, Pre-Exposure Prophylaxis, United States Food and Drug Administration, launch, HIV prevention, long-acting, U.S., Gilead
Halozyme sues Merck over subcutaneous Keytruda as licensing talks fall through
Merck, Legal patent, Subcutaneous Keytruda, Halozyme
Sanofi, Novartis CEOs lambast EU price control as Trump reportedly weighs drug cost parity with other nations
EU, Novartis, CEOs, Transplant Registry Unified Management Program, Financial cost, Parity, sanofi, Investments, Prices, Pharma, Market, nations, U.S.