US Food and Drug Administration
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Intas Pharmaceuticals, Henlius Biotech in Agreement to commercialise serplulimab
Intas Pharmaceuticals has entered into an exclusive license agreement with Shanghai Henlius Biotech for the development and commercialisation of serplulimab…
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Viatris announces US FDA tentative approval of paediatric formulation for children living with HIV
Tentative approval will help enhance access to WHO-recommended paediatric regimen with the goal of improved adherence to HIV treatment for…
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US Department of Health and Human Services, US FDA delegation visit Amneal Pharma’s manufacturing site in India
The company’s manufacturing facility is in Matoda, Gujarat Amneal Pharmaceuticals announced that a delegation of senior members of the US…
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In preparation for future transplants
Lessons learned from world’s first successful transplant of genetically-modified pig heart into human patient. Deborah Kotz, from University of Maryland…
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Axio Biosolutions announces US FDA clearance for Ax-Surgi Surgical Hemostat
Ax-surgi becomes the first and only chitosan-based hemostat cleared for controlling severe surgical bleeding Axio Biosolutions, a biomaterial focussed medtech…
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Glenmark receives US FDA nod for GRC 54276 to treat advanced solid tumours and lymphomas
GRC 54276 is an orally available, small-molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor Glenmark Specialty, the subsidiary of Glenmark Pharmaceuticals,…
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US FDA grants priority review of Takeda’s Biologics License Application (BLA) for dengue vaccine candidate
Regulatory reviews will also progress in dengue-endemic countries in Latin America and Asia The US Food and Drug Administration (FDA)…
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Roche bags US FDA clearance for cobas pure integrated solutions
cobas pure integrated solutions focuses on the automation of manual tasks, reducing the hands-on maintenance time of technicians to just five…
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FDA approves Abbott’s new spinal cord stimulation device
Provides tailored relief to multiple pain areas and adds more treatment options for evolving pain conditions Abbott announced that the…
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FDA approves first cell-based gene therapy to treat adult, paediatric patients with Beta-thalassemia
Beta-thalassemia is a type of inherited blood disorder that causes a reduction of normal haemoglobin and red blood cells in…
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