fda

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, with ALK, RET and ROS1 Fusion Calls on…

2 days ago

Alvotech announces completion of FDA surveillance inspection at Reykjavik facility

May 11, 2026 04:30 ET  | Source: Alvotech Company remains on track for BLA resubmissions in the second quarter REYKJAVIK,…

6 days ago

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 clinical stage regenerative medicine biotechnology company developing cellular…

1 week ago

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, a first-in-class, off-the-shelf Treg therapy, in patients with…

2 weeks ago

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 company that has received modified risk tobacco product…

3 weeks ago

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 efficacy of CK0801 Tregs in transfusion-dependent aplastic anemia.HOUSTON,…

3 weeks ago

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…

1 month 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.…

1 month 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…

1 month 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…

2 months ago