Clinical Trial

U.S. Food and Drug Administration (FDA) Grants Fast Track Designation for Longeveron’s Lomecel-B™ Product for Treatment of Hypoplastic Left Heart Syndrome (HLHS) in Infants

New designation may expedite FDA review and potential approval to address this life-threatening heart condition affecting approximately 1,000 babies per...

Optimi Health Enters Into International Collaborative Research and Supply Agreement With Promises Innovative Recovery Center

Company encouraged by medicinal and therapeutic regulatory developments in Costa Rica Z Strain Psilocybe cubensis Optimi Health, Z Strain Psilocybe...

Journey Medical Corporation Announces 50% Enrollment Milestone Achieved in Phase 3 Clinical Trials Evaluating DFD-29 (Minocycline Modified Release Capsules 40 mg) for the Treatment of Papulopustular Rosacea

Outlook Therapeutics® Re-Submits Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the U.S. Food and Drug Administration

ISELIN, N.J., Aug. 30, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch...

Galecto Announces Publication Supporting the Predictive Role of Galectin-3 on Overall Survival of NSCLC Patients in Peer-Reviewed Scientific Journal

BOSTON, Aug. 29, 2022 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical stage biotechnology company focused on the development...

New REDUCE-IT® Data Show VASCEPA®/VAZKEPA® (icosapent ethyl) Reduced Cardiovascular Events in Patients Who Are Current or Former Smokers

-- Data Show VASCEPA/VAZKEPA Significantly Reduced First and Total Cardiovascular Events in Combined Current and Former Smokers by 23% and...

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5 Adapted Bivalent Vaccine

Submission follows application for Omicron BA.1-adapted bivalent vaccine submitted in July If authorized, both Omicron BA.1-adapted and Omicron BA.4/5-adapted bivalent...

Biomea Fusion Presents Additional Preclinical Data Demonstrating Anti-Tumor Activity and Mechanistic Evidence for BMF-219 in Diffuse Large B-Cell Lymphoma and Multiple Myeloma Models at International Myeloma Society Annual Meeting

Timber Pharmaceuticals Announces Publication of Results from Phase 2b CONTROL Study of FDA-Designated Breakthrough Therapy TMB-001 in the Journal of the American Academy of Dermatology

- Previously reported study demonstrated clinically meaningful efficacy with a favorable safety profile for TMB-001 in moderate to severe congenital...

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