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FDA accepts Shorla’s oral liquid leukaemia drug NDA - Pharmaceutical Technology

The FDA accepted Shorla Oncology's NDA for SH-201, an oral leukemia drug, with a decision due by 30 November 2024. SH-201, acquired in July 2023, offers an alternative for patients struggling with traditional dosage forms. Shorla, bolstered by $35m in Series B funding, aims to expand its oncology portfolio, including SH-201 and previously approved SH-111.


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FDA accepts Shorla’s oral liquid leukaemia drug NDA - Pharmaceutical Technology

The FDA accepted Shorla Oncology's NDA for SH-201, an oral leukemia drug, with a decision due by 30 November 2024. SH-201, acquired in July 2023, offers an alternative for patients struggling with traditional dosage forms. Shorla, bolstered by $35m in Series B funding, aims to expand its oncology portfolio, including SH-201 and previously approved SH-111.

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

Shorla Oncology announced FDA acceptance of its NDA for SH-201, an oral liquid drug targeting leukemia and other cancers, with a PDUFA action date of November 30, 2024. SH-201 offers a palatable treatment option, addressing unmet needs in cancer care. Shorla also progresses with SH-105 and recently raised $35M in Series B funding.

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