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FDA Approval Process

Priority Review New Drug Application Biologics License Application Clinical Trials Marketing Applications Drug Approval Timeline Drug Applications Drug Studies Investigational Drugs Drug Approval for HIV Prevention Advisory Committees Drug Development Drug Approval Foundayo Approval Fast Track Designation Prescription Medications Drug Efficacy Vaccine Applications Clinical Trial Design Premarket Approval Breakthrough Therapy Designation Clinical Trial Phases Drug Approval Applications Vaccine Review Process Drug Submissions Clinical Trial Protocols National Health Priorities Vaccine Approval

FDA Advisers Unanimously Back Moderna’s mRNA Flu Vaccine

Unanimous advisory support advances the shot toward licensure; final FDA action is due by Aug. 5, with CDC coverage unsettled by ACIP’s inability to convene.

Apnimed Pill Cuts Sleep Apnea Events in Phase 3 as Company Seeks FDA Approval

FDA Grants Priority Review to Otsuka’s ADHD Drug Centanafadine With July 24 Decision Date

Sarepta Shares Plunge After ESSENCE Phase 3 Miss in Duchenne Trial

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