Having successfully navigated a two-day, virtual advisory committee review of cancer drug pediatric development plans, the US Food and Drug Administration is ready to embark on its first application-specific virtual meeting, with the oncology panel once again serving as a test bed.
Going Virtual: GSK’s Multiple Myeloma Drug Belantamab Tapped For US FDA Online AdComm In July
Announcement of the 14 July Oncologic Drugs Advisory Committee meeting follows a successful, two-day trial run of the virtual format by the oncology pediatric subcommittee that featured a mix of prerecorded and live sponsor presentations and strict adherence to a call/response approach to ensure orderly conduct.
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
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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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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
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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.