AliveDx Submits FDA 510(k) for MosaiQ AiPlex® Vasculitis Assay to Advance Autoimmune Diagnostics
AliveDx, a global in-vitro diagnostics innovator, today announced it has submitted a 510(k) premarket notification to the U.S. Food...
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First Patient Dosed in CAR-T Trial Using Synecta T1 Nanoparticles
PHILADELPHIA, September 3, 2025 — The first patient has been dosed in a clinical trial evaluating Synecta™ T1 cell-derived...
Spring Health Joins Workday Wellness to Deliver Precision Mental Health
NEW YORK, September 3, 2025 — Spring Health has officially joined the Workday Wellness Partner Program as a Strategic...
FDA Approves LEQEMBI IQLIK Subcutaneous Autoinjector for Maintenance Dosing in Early Alzheimer’s Disease
Eisai Co., Ltd. and Biogen Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved LEQEMBI®...
GeneseeqPrime Gains FDA 510(k) Clearance for Tumor Profiling Kit
TORONTO, Sept. 2, 2025 – Geneseeq Technology Inc. announced that its GeneseeqPrime® NGS Tumor Profiling Assay has received 510(k)...
Nanoscope Strengthens Global Regulatory Pathways for MCO-010 with FDA RMAT and Five EMA Orphan Designations
Nanoscope Therapeutics, a biotechnology company advancing disease-agnostic optogenetic therapies for retinal degenerations, announced a major global regulatory milestone with...
Oncolytics Biotech Shows Favorable Safety for Pelareorep in GI Tumors
SAN DIEGO, Sept. 2, 2025 – Oncolytics Biotech® Inc. (Nasdaq: ONCY), a clinical-stage immunotherapy company, announced updated clinical safety...
Hoth Therapeutics Advances HT-KIT After Preclinical Breakthrough
NEW YORK, Sept. 2, 2025 – Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical innovator, announced encouraging preclinical results...
Sanofi’s Wayrilz Approved in the U.S. as First BTK Inhibitor for Immune Thrombocytopenia
Sanofi has secured U.S. FDA approval for Wayrilz (rilzabrutinib), marking the first Bruton’s tyrosine kinase (BTK) inhibitor approved for...
FDA Clears WIDAPLIK™, Developed with Piramal Pharma Solutions
Piramal Pharma Solutions, a global contract development and manufacturing organization (CDMO), has collaborated with George Medicines to develop WIDAPLIK™,...
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