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FDA Approval Process

New Drug Application Drug Approval Timeline Priority Review Drug Applications Biologics License Application Clinical Trial Phases Drug Approval Applications Clinical Trials Drug Approval Prescription Medications Fast Track Designation Drug Efficacy Marketing Applications Drug Studies Drug Approval for HIV Prevention Advisory Committees Vaccine Applications

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

Cidara’s CD388 Antiviral Achieves Up to 76% Flu Protection in Phase 2b Trial