FDA Considers SH-201 for Treating Certain Leukemias and Cancers

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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