U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb’s Application for CC-486 for Maintenance Treatment of Adult Patients in Remission with Acute Myeloi...
Bristol-Myers Squibb Company (BMY)
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Source: Business Wire
U.S. FDA set target action date of September 3, 2020Application based on results from the Phase 3 QUAZAR®-AML-001 study PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for CC-486, an investigational oral hypomethylating agent, for the maintenance treatment of adult patients with acute myeloid leukemia (AML), who achieved complete remission (CR) or CR with incomplete blood count recovery (CRi), following induction therapy with or without consolidation treatment, and who are not candidates for, or who choose not to proceed to, hematopoietic stem cell transplantation. The FDA granted the application Priority Review and set a Prescription Drug User Fee Act (PDUFA) goal date of September 3, 2020.The NDA submission was based on the efficacy and safety results of the pivotal Phase 3 QUAZAR® AML-001 study, which met the primary endpoint of improved overall surviv
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BMY
Earnings
- 10/31/25 - Beat
BMY
Sec Filings
- 11/18/25 - Form 8-K
- 11/12/25 - Form CERT
- 11/10/25 - Form 8-A12B
- BMY's page on the SEC website