The Consolidated Appropriations Act of 2023 was a star of the US Food and Drug Administration’s Oncologic Drugs Advisory Committee 12 April meeting, where the agency’s expanded accelerated approval withdrawal authority was repeatedly cited as a crucial backstop that reduced the risk associated with a new surrogate endpoint based on minimal residual disease in multiple myeloma.
Minimal Residual Disease Gains Max US FDA AdComm Support For Myeloma Trials
The US FDA’s Oncologic Drugs Advisory Committee unanimously agreed that accelerated approvals should be enabled by multiple myeloma trials using MRD as a surrogate endpoint.
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Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
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March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
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The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.
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The US FDA is receiving more requests for regenerative medicine advanced therapy designation and granting more of them, according to recently reported agency data.
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March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
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The European Medicines Agency is set to issue opinions this week on whether pan-EU marketing approval should be granted to a number of new products.
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The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.