fda

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…

3 days 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…

6 days 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…

7 days 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…

1 week 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…

1 month 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:…

1 month 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…

1 month 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…

2 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…

2 months ago

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 3 trial met its primary endpoint at the…

3 months ago