Bristol Myers Squibb

1 products tracked · names used in filings: Bristol Myers Squibb, Bristol Myers Squibb Co

Upcoming milestones

Thu 13 May 2027🇺🇸 PDUFA datecompany-announcedin 180 days

mezigdomide: PDUFA target action date (relapsed or refractory multiple myeloma (in combination with carfilzomib and dexamethasone))

Bristol Myers Squibb Co (BMY); mezigdomide; NDA; status: set; "mezigdomide July 13 The FDA accepted a New Drug Application for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) in patients with relapsed or refractory multiple myeloma (RRMM), granting a PDUFA date of May 13, 2027."; filed 2026-07-30 · source

Thu 11 Mar 2027🇺🇸 PDUFA datecompany-announcedin 117 days

Reblozyl: PDUFA target action date (myelofibrosis-associated anemia in adults receiving red blood cell transfusions, with concomitant JAK inhibitor therapy)

Bristol Myers Squibb Co (BMY); luspatercept; sBLA; status: set; "The FDA granted a Prescription Drug User Fee Act (PDUFA) date of March 11, 2027."; filed 2026-07-30 · source

Recent milestones

Mon 17 Aug 2026🇺🇸 PDUFA datecompany-announced

iberdomide: PDUFA target action date (relapsed or refractory multiple myeloma)

Bristol Myers Squibb Co (BMY); iberdomide; status: set; "Mezigdomide is the second BMS CELMoD to be granted a PDUFA date this year for an RRMM indication, joining iberdomide , which has a PDUFA date of August 17, 2026."; filed 2026-07-30 · source

Thu 13 Aug 2026🇺🇸 FDA approval

FDA approves Zenbexus (iberdomide hydrochloride), a new medicine

Bristol Myers Squibb; NDA221075; New molecular entity, Priority review; capsule · source

Products

ProductStatusApproved
🇺🇸Zenbexus
iberdomide hydrochloride
Approved2026-08-13

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.