BMY PDUFA Date: Reblozyl

Name: Reblozyl FDA decision
Start: 2027-03-11
End: 2027-03-11

Page updated November 5, 2026·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET

FDA decision (PDUFA) target Mar 11, 2027 · Bristol-Myers Squibb Company · Adults with myelofibrosis-associated anemia receiving red blood cell transfusions, with concomitant JAK inhibitor therapy

Source: Bristol Myers Squibb 8-K 2026-07-30 (EX-99.1, Q2 2026 results). “The FDA granted a Prescription Drug User Fee Act (PDUFA) date of March 11, 2027.”

Key facts

FDA PDUFA target date2027-03-11

Drug / candidateReblozyl (luspatercept)

IndicationAdults with myelofibrosis-associated anemia receiving red blood cell transfusions, with concomitant JAK inhibitor therapy

CompanyBristol-Myers Squibb Company

Market-cap tierLarge

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FAQ

When is the BMY PDUFA date?

The FDA PDUFA target date for BMY (Bristol-Myers Squibb Company) is 2027-03-11 for Reblozyl (luspatercept). Dates are company/FDA-sourced and can slip. Verify against primary filings.

What is BMY's drug Reblozyl?

Reblozyl (luspatercept) is Bristol-Myers Squibb Company's candidate under FDA review for Adults with myelofibrosis-associated anemia receiving red blood cell transfusions, with concomitant JAK inhibitor therapy.