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FDA Approvals

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

The decision follows PALOMA‑3 data demonstrating pharmacokinetic noninferiority plus sharply fewer administration reactions.

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

EU Regulators Back Libtayo as Adjuvant Therapy for High-Risk Cutaneous Squamous Cell Carcinoma

Novartis’ Fabhalta Slows Kidney Function Decline in Final Phase 3 IgAN Results

FDA Approves Libtayo as First Immunotherapy for Adjuvant Treatment of High‑Risk CSCC

Datroway Extends Survival Over Chemotherapy in First-Line TNBC Ineligible for Immunotherapy

Amgen Reports Repatha Cuts First-Event Risk in Primary-Prevention Trial

FDA Grants Accelerated Approval to Forzinity, First Therapy for Barth Syndrome

Roche to Acquire 89bio in Deal Worth Up to $3.5 Billion

FDA Approves J&J’s Inlexzo Bladder Drug-Delivery Device for BCG‑Unresponsive NMIBC