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FDA Authorizes Early Access to Daraxonrasib for Pancreatic Cancer Patients

The decision follows trial results showing the oral drug roughly doubled survival versus chemotherapy.

FDA Issues Second Rejection of Replimune’s RP1 Melanoma Therapy

Spyre Drug Meets Midstage Target in Ulcerative Colitis, Stock Rallies

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

Kodiak’s Zenkuda Hits Phase 3 Goal in Diabetic Retinopathy Prompting Faster FDA Filing

FDA Grants Accelerated Approval to Avlayah for Neurologic Manifestations of Hunter Syndrome

Vertex’s IgA Nephropathy Drug Hits Phase 3 Goals, FDA Filing Slated for March

Zealand Plunges as Roche Obesity Drug Posts 10.7% Weight Loss With Placebo‑Like Tolerability

Moderna Reaches Up to $2.25 Billion LNP Patent Settlement, Pays $950 Million Upfront

FDA Rejects Filing of Moderna’s mRNA Flu Vaccine Over Comparator Dispute

FDA Issues Second Rejection of Atara’s EBV+ PTLD Therapy Tabelecleucel

Lilly and Nimbus Strike Multi-Year AI Deal for Oral Obesity Drugs

FDA Issues Complete Response Letter for Corcept’s Relacorilant in Cushing’s-Related Hypertension

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

Zealand Pharma Unveils ‘Metabolic Frontier 2030’ With Targets for Five Launches

Capricor’s HOPE-3 Trial Reports Cardiac and Muscle Gains in Duchenne Muscular Dystrophy

New aTyr Class Action Expands Investor Window After EFZO-FIT Failure

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

FDA Approves Lurbinectedin Plus Atezolizumab for First-Line Maintenance in Extensive-Stage SCLC

Maze Therapeutics Reports Strong Phase 1 Signal for MZE782, Announces $150 Million Private Placement