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FDA Approval

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FDA Grants Accelerated Approval to Kresladi, First Gene Therapy for Severe Pediatric LAD-1

The one-time autologous treatment won conditional clearance on biomarker gains, requiring long‑term confirmation of benefit.

Grail Shares Plunge About 50% After NHS-Galleri Trial Misses Primary Endpoint

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

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