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…
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…
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,…
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…
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…
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…
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…
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…
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…
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…
