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.

Thanksgiving dinner
Will sponsors enjoy a cornucopia of approvals this month? • Source: Shutterstock

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.

Takeda’s TAK-755 – an enzyme replacement therapy combining apadamtase alfa and cinaxadamtase alfa – is first up with a 16 November 2023 user fee goal date for congenital thrombotic thrombocytopenic purpura (cTTP)

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