Datar Cancer Genetics Receives Landmark US FDA Clearance for CellDx-Tissue, a Comprehensive Genomic Profiling Assay for Solid Tumors Using DNA + RNA
Clearance Recognises CellDx-Tissue's Dual-Analyte DNA and RNA Workflow Across 517 Cancer-Associated Genes,…
Alvotech announces completion of FDA surveillance inspection at Reykjavik facility
May 11, 2026 04:30 ET | Source: Alvotech Company remains on track…
Longeveron Announces Constructive Type C Meeting with U.S. FDA Ahead of Data Readout for ELPIS II Phase 2b Clinical Trial Evaluating Treatment for Hypoplastic Left Heart Syndrome (HLHS)
MIAMI, May 08, 2026 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a…
Cellenkos Announces FDA Clearance of Investigational New Drug (IND) Application for Phase 1b/ 2a Trial of CK0802 in Steroid-Refractory Graft-versus-Host Disease (GVHD)
Multicenter, open-label study will evaluate the safety and preliminary efficacy of CK0802,…
Philip Morris International Announces U.S. FDA Reauthorization of IQOS as a Modified Risk Tobacco Product
A pioneer in smoke-free tobacco products, Philip Morris International is the only…
Cellenkos, Inc. Announces FDA Clearance to Initiate Phase 2 Clinical Trial of CK0801 (Allogeneic Cord Blood-Derived Tregs) for Aplastic Anemia
Phase 2 multicenter, open-label study (NCT07499102) will evaluate the safety and clinical…
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…
