Siren Biotechnology Announces FDA Clearance of First IND, Advancing Company to Clinical Stage
SAN FRANCISCO, Jan. 28, 2026 (GLOBE NEWSWIRE) -- Siren Biotechnology, pioneers of…
FDA Accepts LEQEMBI IQLIK (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimers Disease under Priority Review
If approved, LEQEMBI IQLIK would be the first and only anti-amyloid treatment…
Best Weight Loss Pills for 2026? FDA Approves First Oral GLP-1 as Patients Evaluate Wegovy, Zepbound, and Telehealth Access Pathways
Newark, DE, Dec. 29, 2025 (GLOBE NEWSWIRE) -- The term "best" reflects…
ImmuCell Announces Strategic Focus on First Defense After Receiving an FDA Incomplete Letter for Re-Tain
December 24, 2025 13:05 ET | Source: ImmuCell Corporation PORTLAND, Maine, Dec.…
U.S. FDA Approves Agios AQVESME (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia
AQVESME is the only FDA-approved medicine for anemia in both non-transfusion-dependent and…
Milestone Receives FDA Approval of CARDAMYST (etripamil) as First and Only Self-Administered Nasal Spray for Adults with Paroxysmal Supraventricular Tachycardia (PSVT)
First FDA approved treatment in 30+ years for more than 2 million…
Ascendis Announces Extension of FDA Review Period for TransCon CNP (navepegritide) for Children with Achondroplasia
November 25, 2025 18:15 ET | Source: Ascendis Pharma – Prescription Drug…
Vera Therapeutics Submits Biologics License Application to U.S. FDA through Accelerated Approval Program for Atacicept for the Treatment of Adults with IgA Nephropathy
Atacicept received FDA Breakthrough Therapy Designation for the treatment of IgANORIGIN Phase…
Ofirnoflast (HT-6184) Receives Orphan Drug Designation from U.S. FDA for Myelodysplastic Syndromes
LEHI, Utah, Oct. 23, 2025 /PRNewswire/ -- Halia Therapeutics, Inc., a clinical-stage biopharmaceutical…
Revolution Medicines Awarded Voucher for Daraxonrasib (RMC-6236) Under FDA Commissioner’s National Priority Voucher Pilot Program
REDWOOD CITY, Calif., Oct. 16, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc.…
