News FDA names a new CDER director, choosing a biotech vet The FDA has rounded out its senior leadership by naming biopharma industry executive George Tidmarsh to the role of CDER director.
News Sarepta resists as FDA seeks pause on Elevidys use Sarepta has defied an FDA request to halt all use of its gene therapy for Duchenne muscular dystrophy, creating an intriguing regulatory impasse.
News GSK's growth plans dented by Blenrep setback FDA advisors have voted that the benefit/risk profile of GSK's multiple myeloma therapy, Blenrep, does not support its approval in the US.
News HHS layoffs are finalised as thousands of pink slips arrive Federal staffers voice their anger and disgust as thousands of the Trump administration's reduction-in-force job losses are finalised.
News Just how radical is the FDA's complete response letter move? The FDA says publishing complete response letters for medicines is an act of "radical transparency," but it is not as revolutionary as it seems.
News FDA loosens restrictions on first-gen CAR-T therapies There is enough experience with the first wave of autologous CAR-T therapies to allow strict rules ensuring their safe use to be relaxed, says FDA.
News Takeda gets first OK for orexin narcolepsy drug, in China China has become the first country to approve Takeda's first-in-class orexin agonist, oveporexton, for the sleep disorder narcolepsy.
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