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A routine document released by the FDA on Wednesday raised new questions about the agency’s rejection — and subsequent approval — of Sarepta’s Duchenne muscular dystrophy (DMD) treatment Vyondys 53. Read More
Valtoco was approved for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure. Read More
The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee split yesterday in a 6-6 vote over Durect’s Posirim (bupivacaine extended-release solution) for post-surgical analgesia. Read More