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FDA Approves Aqvesme for Thalassemia Anemia, First U.S. Therapy for Both Patient Groups

Approval reflects late-stage efficacy results with use restricted under a REMS requiring frequent liver tests.

Neurocrine’s Valbenazine Misses Phase 3 Goals in Dyskinetic Cerebral Palsy

Lilly Files Orforglipron Obesity Pill With FDA After Trial Shows Weight-Loss Maintenance

FDA Clears GSK’s Exdensur as First Twice-Yearly Add-On for Severe Eosinophilic Asthma

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

Lancet Phase III Trial Finds Proton Therapy Improves 5-Year Survival in Oropharyngeal Cancer

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

Ianalumab Plus Eltrombopag Extends Disease Control in Phase 3 ITP Study Published in NEJM

Epcoritamab Added to R2 Yields Large Efficacy Gains in Relapsed Follicular Lymphoma

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

FDA Grants Full Approval to Jaypirca for Relapsed CLL/SLL After Covalent BTK Therapy

Pharvaris’ Oral HAE Drug Deucrictibant Delivers Rapid Relief in Pivotal Phase 3

Junshi’s Subcutaneous Toripalimab Matches IV in Phase 3 NSCLC Trial as Company Prepares NDA

Bayer Stroke Drug Asundexian Hits Phase III Goals, Shares Jump

FDA OKs RVO Use and Monthly Dosing for Regeneron’s Eylea HD

FDA Approves Koselugo for Adults With NF1-Related Plexiform Neurofibromas

EMA Panel Backs Higher-Dose Spinraza for 5q SMA

FDA Approves Poherdy as First Interchangeable Biosimilar to Perjeta for HER2-Positive Breast Cancer