fda

LEX Diagnostics Receives FDA 510(k) Clearance and CLIA Waiver for LEX VELO System

Ultra-fast point-of-care molecular diagnostics platform for key respiratory pathogens delivers results in under ten minutes February 16, 2026 05:00 ET…

2 months ago

Novel Anti-Fibrotic Drug AK3280 Cleared by FDA to Initiate Phase 2 Proof-of-Concept Clinical Trial in IPF

SHANGHAI, Feb. 12, 2026 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the U.S. Food and Drug…

2 months ago

AB Science announced that the Food and Drug Administration (FDA) granted the status of Minor Use in Major Species (MUMS) for Masivet in the treatment of canine mast cell tumors

PRESS RELEASE AB SCIENCE ANNOUNCES THAT THE FDA HAS GRANTED THE STATUS OF MINOR USE IN MAJOR SPECIES DESIGNATION FOR…

2 months ago

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…

2 months 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…

2 months 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…

3 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…

3 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…

3 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…

4 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:…

4 months ago