Tired Of Winning? When It Comes To US FDA Appeals, “Denied” Can Still Mean Victory
Success rate for sponsors pursuing appeals of FDA rejections is much higher than reported by agency, a leading US regulatory law firm argues. Agile Therapeutics’ “loss” of an appeal is a good example of how sponsors can still benefit even if their formal request is denied.
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Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning
Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.
The latest drug development news and highlights from our US FDA Performance Tracker include a Neulasta biosimilar approval for Sandoz, novel approvals for Celgene's Reblozyl and Giskit B.V.'s ExEm Foam, and a submission for Regeneron's Ebola candidate.