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FDA Approves At‑Home Weekly Subcutaneous Starter Dose for Leqembi

Relying on pharmacokinetic bioequivalence rather than new outcome trials, the agency cleared at‑home initiation to expand access and reduce infusion demand.

Grail’s Galleri Misses NHS Trial Target and Seeks More Follow‑Up Data

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

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