fda

Mesoblast Receives IND Clearance From FDA to Directly Proceed to Registrational Trial for Approval of Ryoncil in Duchenne Muscular Dystrophy – CORRECTION

April 10, 2026 16:09 ET  | Source: Mesoblast Limited Working with Parent Project Muscular Dystrophy and the Duchenne Registry on…

2 weeks ago

Replimune Receives Complete Response Letter from the FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma

April 10, 2026 17:02 ET  | Source: Replimune, Inc. WOBURN, Mass., April 10, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc.…

2 weeks ago

Supira Medical Announces FDA Approval for SUPPORT II Pivotal Trial, Advances in Cardiogenic Shock, and Appointment of D. Keith Grossman to Board of Directors

Milestones underscore clinical progress and strengthen commercial foundationLOS GATOS, Calif., April 8, 2026 /PRNewswire/ -- Supira Medical, Inc. (Supira), a clinical-stage…

3 weeks ago

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…

1 month 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…

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…

2 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…

2 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…

2 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…

2 months ago
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