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Vaibhavi M.
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Sapience Therapeutics Achieves Phase 2 Milestone for Lucicebtide in Newly Diagnosed Glioblastoma
Sapience Therapeutics releases Phase 2 data for lucicebtide plus chemoradiation in newly diagnosed GBM, covering efficacy, pharmacodynamics, and safety.
Vaibhavi M.
FDA Issues Draft Guidance on Platform CMC Knowledge to Streamline Gene Therapy Submissions
FDA draft guidance allows gene therapy sponsors to leverage platform CMC and prior nonclinical data to streamline submissions, with early engagement encouraged.
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HealthPartners Neuroscience Center Receives FDA Warning Letter Over GLP Mixture Uniformity Failures
FDA issues Warning Letter to HealthPartners Neuroscience Center for GLP failures in mixture uniformity verification across two nonclinical studies.
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Karyopharm Achieves Phase 3 SENTRY Primary Endpoint for Selinexor-Ruxolitinib Combination in Myelofibrosis
Karyopharm's SENTRY Phase 3 trial meets primary endpoint, nearly doubling SVR35 rates for selinexor-ruxolitinib vs. ruxolitinib alone in myelofibrosis.
Vaibhavi M.
