Takeda pulls dengue vaccine application after FDA requests more data
Takeda has withdrawn an FDA application for its dengue vaccine candidate following a request by regulators for more data.
The Japanese biotech filed a biologics license application for TAK-003 last year, announcing in November that it scored priority review status, which typically shortens the FDA’s decision-making process to six months. On Tuesday, however, the company revealed that it voluntarily pulled the BLA after regulators “sought additional data not captured within the TAK-003 clinical trial protocol,” which the agency had previously reviewed and accepted.
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