Government ❯ Regulation ❯ FDA

Drug Approval Process

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

Moderna Posts Q2 Revenue Beat as Norovirus Trial Misses Interim Goal

The result sharpens focus on an August 5 FDA decision for its seasonal flu shot that could determine the company’s near-term commercial path.

FDA Staff Flags Major Flaws in Capricor’s Deramiocel Data

Kalshi Opens Betting Markets for Phase 3 Drug Trials and FDA Decisions

FDA Agrees Three‑Year Phase I/II Data Can Support uniQure’s AMT‑130 Accelerated BLA

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

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