The FDA and Sarepta have had a controversial history with the accelerated approvals of the firm’s earlier drugs for Duchenne muscular dystrophy – but the company’s investigational gene therapy, SRP-9001, now under a priority review, could be a genuine breakthrough.
The US Food and Drug Administration is to decide by 29 May 2023 on whether or not to approve SRP-9001, Sarepta Therapeutics’s gene therapy for Duchenne, which many hope will be a breakthrough against the debilitating and eventually fatal inherited muscle wasting disease.
The FDA has decided to review the drug’s data early via a priority review, well before Sarepta’s Phase III placebo-controlled...
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Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
