FDA priority voucher drug vote excluded review staff, involving top officials in a major procedural shift.
Browsing: Regulatory & Approvals
Regulatory updates, drug approvals, submissions, and compliance developments from authorities like FDA, EMA, and others.
Novo Nordisk vision loss compensation awarded to four Danish patients using Wegovy and Ozempic, totaling $123,253.
FDA quick clarifications allow biotechs to email agency staff, enhancing communication and expediting drug development processes.
Pfizer settlement Texas involves $41.5 million over allegations of altered testing methods for an ADHD drug.
Regeneron Eylea HD approvals enhance its market position with two new indications, intensifying competition with Roche’s Vabysmo.
Sarepta FDA warning highlights heart risk in Elevidys therapy, affecting Duchenne muscular dystrophy patients.
Arrowhead FDA approval for Redemplo marks its transition to a commercial-stage company, targeting a rare genetic disorder.
Domestic Generic Drug Fast-Track Review Program aims to expedite approval for drugs made from domestic materials.
Generic mifepristone approval by FDA expands access to abortion care, offering a new option for patients.
FDA warning letters target misleading advertising by Novo Nordisk, Eli Lilly, and Hims, urging improved transparency and compliance.