Belite Bio files Japan NDA for tinlarebant under Sakigake designation for Stargardt disease type 1
BLTE•Belite Bio files Japan NDA under Sakigake pathway
Belite Bio filed a Japan NDA with the MHLW for tinlarebant to treat Stargardt disease type 1 under the Sakigake pathway.
- The FDA accepted the US NDA for priority review, setting a PDUFA target action date of Feb. 12, 2027.
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