FDA Grants Priority Review to Imfinzi-Enfortumab Vedotin Regimen for Muscle-Invasive Bladder Cancer

As reported on PharmaBiz, the FDA has accepted AstraZeneca’s supplemental Biologics License Application for durvalumab plus neoadjuvant enfortumab vedotin in patients with muscle-invasive bladder cancer who cannot receive or have…

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Singapore Approves Wegovy for MASH With Moderate to Advanced Liver Fibrosis

Semaglutide 2.4 mg becomes Singapore’s first approved therapy for adults with noncirrhotic metabolic dysfunction-associated steatohepatitis and F2-F3 fibrosis. As reported on the Manila Times, Singapore’s Health Sciences Authority (HSA) has…

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Organoid Advances Could Open New Paths for Spinal Cord and Peripheral Nerve Repair

As reported on News Medical, researchers are increasingly exploring laboratory-grown organoids as potential tools for repairing damage caused by spinal cord and peripheral nerve injuries. A review published in Engineering…

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Novel Therapies and the FDA

Twenty-six Novel Therapies have been FDA-approved so far this year. Medical journals, including "The Lancet", see this as a difficult task. The Agency must maintain strict safety rules while simultaneously…

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