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FDA Approval Process

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Sarepta Shares Plunge After ESSENCE Phase 3 Miss in Duchenne Trial

The company will seek FDA guidance on converting its exon-skipping drugs from accelerated to full approval.

Inhibrx Drug Extends PFS in Chondrosarcoma Phase 2 as Shares Jump Over 70%

Veradermics Advances Long-Acting Oral Minoxidil Into Phase 3 U.S. Trials