News FDA seeks input into 'opaque' priority voucher scheme FDA seeks public input on controversial priority voucher scheme amid concerns about its transparency and legality.
News FDA approves higher Wegovy dose via 4th priority voucher The US FDA has approved a fourth product via its new National Priority Voucher Programme - a 7.2 mg dose of Novo Nordisk's weight loss drug Wegovy.
News FDA publishes advice on animal testing alternatives New draft guidance from the FDA is urging pharma companies to accelerate efforts to transition from animal testing to non-animal alternatives.
News FDA approves leucovorin – but not for autism The FDA stops short of approving leucovorin for autism, but will its clearance for ultra-rare condition CFD-FOLR1 lead to more off-label prescribing?
News FDA cuts testing requirements for biosimilars once again The FDA has issued additional guidance that aims to make it easier for drugmakers to bring biosimilars of patent-expired biologic drugs to market.
News CBER chief Vinay Prasad to leave FDA once again For the second time in less than a year, Vinay Prasad has departed from the FDA, after a string of controversial regulatory decisions.
News Infex chases after Insmed with bronchiectasis trial win UK biotech Infex is in hot pursuit of Insmed's Brinsupri, the only approved therapy for non-CF bronchiectasis, with its quarterly-dosed antibody.
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