FDA Priority Review Granted to Garetosmab for FOP
Rare Disease Biologic Advances Toward U.S. Approval – February 19, 2026 | Tarrytown, New York Regeneron Pharmaceuticals announced that...
Monoclonal Antibody
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TuHURA Files IND for TBS-2025 in AML Trial
TAMPA, FLORIDA, UNITED STATES — February 17, 2026 TuHURA Biosciences has filed an Investigational New Drug (IND) application with...
FDA Grants Breakthrough Status to Ianalumab in Sjögren’s
Basel, January 16, 2026 — Novartis announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation...
Apogee Shows Durable Phase 1b Asthma Data for IL-13 Biologic
SAN FRANCISCO & BOSTON | January 6, 2026 — Apogee Therapeutics has reported positive interim results from a Phase...
Omeros Details FDA Approval Path for First TA-TMA Therapy
SEATTLE, Dec. 26, 2025 — Omeros Corporation has announced a revised date for its upcoming conference call to discuss...
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Japan Approves Dupixent for Children With Severe Asthma
TOKYO, Japan — December 23, 2025 — The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval...
FDA Clears Aqualung’s Phase 2a Study in Lung Fibrosis
December 22, 2025 | Juno Beach, Florida — Aqualung Therapeutics announced that the U.S. Food and Drug Administration (FDA)...
Eisai Files NDA in Japan for Subcutaneous Leqembi to Expand Alzheimer’s Access
TOKYO & STOCKHOLM — November 28, 2025. Eisai, in partnership with BioArctic, has submitted a New Drug Application (NDA)...
Tonix, MGH Collaborate on Phase 2 Trial of TNX-1500 to Prevent Kidney Transplant Rejection
CHATHAM, N.J., November 4, 2025: Tonix Pharmaceuticals Holding Corp. has announced a strategic collaboration with Massachusetts General Hospital (MGH)...
Vir Completes Phase 3 Enrollment for Hepatitis Delta Trial
San Francisco, California – November 3, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR), a clinical-stage biopharmaceutical company focused on harnessing...
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