Otsuka FDA approval marks a milestone with Voyxact for IgA nephropathy, a chronic kidney disease.
Browsing: Regulatory & Approvals
Regulatory updates, drug approvals, submissions, and compliance developments from authorities like FDA, EMA, and others.
Novartis FDA Approval Itvisma expands treatment for spinal muscular atrophy to older patients, priced at $2.59 million.
Takeda rare disease drug is under FDA investigation following a patient death and reports of neutralizing antibodies.
FDA priority voucher drug vote excluded review staff, involving top officials in a major procedural shift.
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.