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CORRECTING & REPLACING — MBX Biosciences Announces Successful End-of-Phase 2 FDA Meeting and Provides Phase 3 Development Plan for Once-Weekly Canvuparatide for Hypoparathyroidism

Following End-of-Phase 2 meeting, MBX remains on track to initiate Phase 3 in Q3 2026 March 09, 2026 10:21 ET…

2 months ago

Paingone Plus TENS Pen Featured in 2026 Consumer Report Examining FDA Clearance Status, TENS Pain Therapy Research, and Portable Pain Relief Device Verification

Tukwila, WA, March 05, 2026 (GLOBE NEWSWIRE) -- This report examines publicly available marketing statements and published research literature. Where…

2 months ago

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 months 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…

3 months 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…

3 months 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…

3 months 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…

3 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…

3 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…

3 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…

3 months ago
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