FDA Approved: IMKELDI — Original Application (Shorla Oncology Inc.,)

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Summary

FDA approved IMKELDI (imatinib oral) under an original NDA from Shorla Oncology, authorizing a new imatinib product for several cancers including chronic myeloi…

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Diseases / indications

• Acute Lymphoblastic Leukemia
• Chronic Myeloid Leukemia
• Dermatofibrosarcoma Protuberans
• Gastrointestinal Stromal Tumor

Drugs mentioned

• IMKELDI (Imatinib)

Snippet

ORIG AP for IMKELDI (IMATINIB ORAL)