8 April 2024 - Second FDA acceptance for an NDA filing by Shorla Oncology announced in 2024.
Shorla Oncology announced today that the US FDA has accepted for review the company’s new drug application for SH-201, the first palatable oral liquid of the related chemotherapeutic agent to treat certain forms of leukaemia and other cancers. The Agency assigned a PDUFA action date of 30 November 2024.