fda

Novartis Cosentyx receives FDA approval for pediatric patients aged 12+ with moderate to severe hidradenitis suppurativa

Cosentyx is the only IL-17A inhibitor approved for this population, and the first differentiated mechanism in nearly a decade1-3 HS often emerges around…

4 days ago

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…

1 week 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 weeks 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 weeks 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…

4 weeks 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…

4 weeks 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…

4 weeks 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…

4 weeks 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…

1 month 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…

1 month ago
Show more Posts