Takeda Pharmaceutical Co. Ltd. is looking forward to US FDA action on two novel agents during the month of November. If they are both approvals, they could provide welcome new storylines after the company pulled the BLA for its dengue vaccine Qdenga in July and decided to withdraw targeted lung cancer therapy Exkivity (mobocertinib) from the market last month following failed in a Phase III confirmatory trial.
November US FDA User Fee Calendar: Takeda On Tap; Small Molecules For Cancer
Takeda hopes for good news on fruquintinib and TAK-755, while Bristol and SpringWorks share a goal date for their breakthrough-designated cancer treatments.
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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.