Takeda, Japan's largest drugmaker, said on Monday U.S. regulators have put back the date for a response to Takeda's application for approval of a key ulcer drug candidate due to a delay in the examination process.
Takeda said the U.S. Food and Drug Administration put off the deadline on possible approval of TAK-390MR by three months to Jan. 31 from the originally scheduled Oct. 31.
Reuters
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