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FDA Approval

BiVACOR Clinical Study Safety Testing Therapeutic Development Diagnostic Tools Phase 3 Studies Drug Development Investigational New Drug Application IND Clearance Gene-Edited Organs Investigational New Drug Drug Repurposing Medical Devices Phase 3 Trials Gene Therapy Approval Process Ziftomenib Trials Bridge to HOPE Study

Indomo's ClearPen, an At-Home Acne Steroid Injector, Set for Phase 2 Trial Next Year

Regulators must still review Phase 2 then Phase 3 results before any prescription rollout.

NEJM Study Finds 95% Long-Term Success for ADA-SCID Gene Therapy

Crinetics Wins FDA Approval for Oral Acromegaly Drug Palsonify as JMP Lifts Price Target

FDA Approves First Eye Implant to Preserve Vision in Rare Macular Telangiectasia