The FDA has accepted the NDA of SH-201 for review as a potential treatment for certain forms of leukemia and other cancers.
- The new drug application (NDA) for SH-201 has been accepted for priority review by the FDA.
- A Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2024, has been set.
- This marks the second FDA acceptance for an NDA filing by the company, Shorla Oncology, in 2024, as SH-105 was accepted in January.
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