The US FDA convened five advisory committee meetings to discuss NMEs and novel biologics during the first half of the year. Two of the meetings took place after the user fee goal date had passed, suggesting the value that the FDA places on scientific advice for challenging applications.
US FDA Calls ’Em Like Its Advisory Committees See Them
So far this year, when the agency has taken action on NMEs that went before advisory committees, the FDA decision has matched the committee vote.
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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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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.
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Two investigational products have made it onto the European Medicines Agency’s priority medicines scheme so far this year. Meanwhile, of the 14 products that entered the scheme last year, six were advanced therapies.