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Sarepta Therapeutics (SRPT) says the FDA is considering accelerated approval of eteplirsen for the treatment of Duchenne muscular dystrophy. The agency has requested [[SRPT]] provide additional information from its existing dataset to help facilitate a decision on its acceptability for a New Drug Application filing under the Subpart H Accelerated Approval regulatory pathway. Shares -0.4% AH.

Sarepta Therapeutics (SRPT) says the FDA is considering accelerated approval of eteplirsen for the treatment of Duchenne muscular dystrophy. The agency has requested SRPT provide additional information from its existing dataset to help facilitate a decision on its acceptability for a New Drug Application filing under the Subpart H Accelerated Approval regulatory pathway. Shares -0.4% AH. Post your comment!

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