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Irish entrepreneurs grapple with complexities of endlessly fascinating South Africa – The Irish Times

2024 EY Entrepreneur of the Year Award Finalists Panel

This year’s finalists in the EY Entrepreneur have just been announced and it’s a bumper group.

Shortlist for 2024 EY Entrepreneur of the Year awards revealed

Shorla Oncology Announces FDA Filing Acceptance of New Drug Application to Treat Certain Forms of Leukemia and Other Cancers

CAMBRIDGE, Mass., April 08, 2024 Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for SH-201, the first palatable oral liquid of the related chemotherapeutic agent to treat certain forms of leukemia and other cancers. The Agency assigned a Prescription Drug User Fee Act ("PDUFA") action date of November 30, 2024.

FDA Accepts NDA for SH-201 in Leukemia and Other Cancers

The FDA has accepted for review the new drug application for SH-201 for the treatment of patients with certain forms of leukemia and other cancers.

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