Precision Robotic CERTA Access System Records First U.S. Clinical Outcomes
Fort Lauderdale, FL – September 4, 2025 – The first U.S. clinical cases using the CERTA™ Access System, a...
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Senhwa’s CX-5461 Gains FDA IND Clearance and NCI Support to Advance in MYC-Driven Lymphoma
Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has...
IDEAYA Biosciences Enrolls First Patient in Phase 1/2 Combination Trial of IDE397 and Trodelvy® in MTAP-Deletion NSCLC
IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company, announced the enrollment of the first patient in its...
Covariate Adjustment Sharply Improves Clinical Trial Precision
MONT-SAINT-GUIBERT, Belgium, September 4, 2025 — A recent peer-reviewed study in The Journal of Pain demonstrates that a streamlined...
NeuroSense Therapeutics Announces $500,000 Private Placement at Premium to Market Price
NeuroSense Therapeutics Ltd. (NASDAQ: NRSN), a late-clinical stage biotechnology company developing therapies for neurodegenerative diseases, has entered into a...
FDA Approves First RNA Therapy for Hereditary Angioedema Prophylaxis
CARLSBAD, Calif., August 21, 2025 — The U.S. Food and Drug Administration (FDA) has approved DAWNZERA™ (donidalorsen), the first...
FDA Grants Breakthrough Therapy Designation to HERNEXEOS® for First-Line Treatment of HER2-Mutant Advanced NSCLC
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for HERNEXEOS®...
Natural Vitamin D3 Supplement Supports Year-Round Sufficiency
FORT LAUDERDALE, September 3, 2025 – As daylight dwindles in parts of the northern hemisphere, maintaining adequate vitamin D...
Andelyn Biosciences Partners with Tern Therapeutics for Late-Stage Manufacturing of AAV Gene Therapy for CLN2 Batten Disease
Andelyn Biosciences, a leading cell and gene therapy CDMO, has partnered with Tern Therapeutics to perform late-stage Process Performance...
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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