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FDA Approvals

Drug Approval Process Drug Development Drug Safety Novo Nordisk Medical Devices Biologics License Application New Drug Applications Drug Indications Drug Approvals Label Expansions

Taysha Advances Rett Gene Therapy Program With Pivotal Dosing, FDA Alignment and Q2 Data Timeline

FDA feedback supports a streamlined route to a potential BLA.

FDA Clears J&J’s Icotyde, First Oral IL-23 Psoriasis Therapy for Ages 12 and Up

Iovance Shares Hit Record After UBS Doubles Price Target

Lilly Launches FDA-Cleared Monthly Zepbound KwikPen on LillyDirect at $299 Starter Price

Sarepta Reports 3-Year EMBARK Data Showing Elevidys Slows Duchenne Progression

FDA Clears Medtronic’s MiniMed Go App Linking InPen With Abbott’s Instinct CGM

FDA Approves First Wegovy Pill for Chronic Weight Management

AstraZeneca’s LATIFY Phase 3 Finds No Survival Benefit for Ceralasertib Plus Imfinzi in Pre-Treated NSCLC

FDA Approves Rybrevant Faspro, a 5‑Minute Subcutaneous Amivantamab for EGFR‑Mutated Lung Cancer

FDA Clears First New Oral Gonorrhea Antibiotics in Over 30 Years

Kyverna CAR-T Delivers Positive Phase 2 Topline in Stiff Person Syndrome as Shares Jump

FDA Approves Amgen’s Uplinza for Generalized Myasthenia Gravis

FDA Approves Orladeyo Oral Pellets to Prevent HAE Attacks in Children Ages 2 to Under 12

FDA Approves One-Time Intrathecal Gene Therapy Itvisma for Older SMA Patients

FDA Approves Breyanzi for Marginal Zone Lymphoma After Two or More Therapies

FDA Approves Novartis’ Itvisma for SMA Patients Ages 2 and Up

Bayer Stroke Drug Asundexian Hits Phase III Goals, Shares Jump

FDA Approves Darzalex Faspro as First Therapy for High-Risk Smoldering Multiple Myeloma

Sarepta Shares Plunge After ESSENCE Phase 3 Miss in Duchenne Trial

Orchestra BioMed Starts U.S. Virtue Coronary Balloon Trial as Terumo Reworks Deal With $30M Support