Hemex Health Receives FDA Breakthrough Device Designation for Gazelle Hb Variant Test
PORTLAND, Ore., Feb. 06, 2026 (GLOBE NEWSWIRE) -- Hemex Health, a medical…
Pharming Group receives Complete Response Letter from U.S. FDA for sNDA for Joenja (leniolisib) in children aged 4 to 11 years with APDS
Leiden, the Netherlands, February 1, 2026: Pharming Group (Euronext: PHARM; Nasdaq: PHAR)…
QTX-2101 Awarded FDA Fast Track Designation for the Treatment of Acute Promyelocytic Leukemia
CHICAGO, Jan. 29, 2026 (GLOBE NEWSWIRE) -- Quetzal Therapeutics, a biopharmaceutical company…
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…
