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Drug Approval Process

Clinical Trials Biologics License Application Quality Control Counterfeit Drug Enforcement Drug Shortage Management Elevidys Clinical Holds Healthcare Policies Voluntary Hold MDMA Therapy New Drug Application Orforglipron Approval Vaccine Approval Moderna Application Public Health Public Health Policy Placebo-Controlled Studies NDA Submission Executive Orders Agency Oversight Wellcovorin Withdrawal

Compass Pathways Rises on Q1 Beat as FDA Accepts Rolling Review for COMP360

The next milestone is a 26-week Phase 3 data readout in early Q3.

uniQure Soars 36% After FDA Biologics Chief Vinay Prasad Announces April Exit

FDA Demands Placebo-Controlled Trial for UniQure’s Huntington’s Gene Therapy

Gym-Goers Turn From Steroids to Peptide Injections

Lilly’s Daily Obesity Pill Sustains Weight Loss After Switch From Wegovy or Zepbound

FDA Setback Puts uniQure’s Huntington’s Gene Therapy Filing in Doubt

FDA Accepts Replimune’s Resubmitted RP1 Melanoma Filing, Sets April 2026 Decision