fda

Hemex Health Receives FDA Breakthrough Device Designation for Gazelle Hb Variant Test

PORTLAND, Ore., Feb. 06, 2026 (GLOBE NEWSWIRE) -- Hemex Health, a medical diagnostics company focused on decentralized testing for blood-based…

1 month ago

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) today announced that the U.S. Food and Drug…

1 month ago

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 focused on developing treatments for rare diseases, announced…

2 months ago

Siren Biotechnology Announces FDA Clearance of First IND, Advancing Company to Clinical Stage

SAN FRANCISCO, Jan. 28, 2026 (GLOBE NEWSWIRE) -- Siren Biotechnology, pioneers of Universal AAV Immuno-Gene Therapy for cancer, today announced…

2 months ago

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 to offer at-home injection options for initiation and…

2 months ago

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 common consumer search phrasing and is used here…

3 months ago

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. 24, 2025 (GLOBE NEWSWIRE) -- ImmuCell Corporation (Nasdaq:…

3 months ago

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 transfusion-dependent alpha- or beta-thalassemiaMarketed under AQVESME brand name…

3 months ago

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 Americans with PSVT Novel nasal spray designed to rapidly…

3 months ago

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 User Fee Act (PDUFA) goal date extended by…

4 months ago