Category News

FDA grants Breakthrough Therapy status to Raludotatug Deruxtecan for CDH6+ ovarian cancers

FDA grants Breakthrough Therapy Designation to Raludotatug Deruxtecan for CDH6+ platinum-resistant ovarian and related cancers previously treated with bevacizumab Raludotatug deruxtecan (R-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment…

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EU approves Novo Nordisk’s oral semaglutide—the first oral GLP-1 RA to cut cardiovascular risks

EU approves first oral GLP-1 RA to cut cardiovascular risk Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved an update to the Rybelsus® (oral semaglutide) label to reflect the cardiovascular…

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Cascade Bio Raises $6M to Accelerate Growth of Next-Gen Biocatalysts

Cascade Bio Secures $6 Million to Advance Biocatalyst Innovation and Transform Biomanufacturing In a world grappling with climate change, supply chain disruptions, and the growing demand for sustainable manufacturing, biotechnology companies are racing to create alternatives to petrochemical-based production. Cascade…

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JCR Pharma Shares Long-Term Data on Pabinafusp Alfa in MPS II at ICIEM 2025

JCR Pharmaceuticals Showcases Landmark Five-Year Clinical Data on Pabinafusp Alfa at ICIEM 2025, Reinforcing Transformative Potential for Patients with Hunter Syndrome and Expanding Pipeline of Brain-Penetrant Enzyme Replacement Therapies In early September 2025, the city of Kyoto, Japan, became the…

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FDA

FDA Expands Approval of VONVENDI for Von Willebrand Disease in Adults and Children

FDA Expands Approval of Takeda’s VONVENDI®, First Recombinant von Willebrand Factor Therapy, to Include Routine Prophylaxis for Adults and Children with von Willebrand Disease Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK), a global biopharmaceutical leader with a longstanding commitment to advancing therapies…

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