fda

U.S. Food and Drug Administration (FDA) Accepts Tevas New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-‘749) for the Once-Monthly Treatment of Schizophrenia in Adults

Olanzapine long-acting injectable (LAI) suspension (TEV-'749) has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation1If…

3 days ago

FDA Grants Breakthrough Device Designation to Two Rapid Tests Targeting Critical Drug-Resistant Pathogens

SANTA MARIA, Calif. and GUIPRY, France, Feb. 18, 2026 /PRNewswire/ -- In a major step forward against Antimicrobial Resistance (AMR), NG…

6 days ago

FDA 510(k) Clearance Establishes Broad Intended Use for Copan’s PhenoMATRIX, Expanding Clinical Microbiology Capabilities

MURRIETA, Calif., Feb. 17, 2026 /PRNewswire/ -- Copan Group announced today that PhenoMATRIX®, its automated image assessment software used with…

1 week ago

Nicox Announces Positive Feedback from pre-NDA Meeting with U.S. FDA for NCX 470

Press Release Nicox Announces Positive Feedback from pre-NDA Meeting with U.S. FDA for NCX 470U.S. NDA submission on track for…

1 week ago

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…

1 week 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 weeks 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 weeks 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 weeks 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…

3 weeks 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…

4 weeks ago
Show more Posts