Tools / Markets / Companies Bristol-Myers Squibb Pharmaceutical companyAI Labelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesAI Labelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. . FDA records under 11 spellings of its name, each linked to the record. See the Bristol Myers Squibb group view .
As of Nov 15, 2026, FDA's public records list Bristol-Myers Squibb and its 13 subsidiaries with 360 drug applications, 91 510(k) clearances, 7 drug recalls, 5 OPDP letters, 2 warning letters and 1 complete response letter. The most recent is an OPDP letter dated Dec 15, 2025: Untitled letter: COBENFY.
Group recordsAI Labelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field. : 466 , 14 entitiesDrug applications : 360 510(k) clearances : 91 Drug recalls : 7 OPDP letters : 5 Records by Year Share Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Bristol-Myers Squibb and its 13 subsidiaries
How to read this A hatched bar is a year that is not over, so its count covers only part of the year.
2 2017 2
0 2018 2018 0 vs 2017−2
1 2019 1 vs 2018+1
3 2020 2020 3 vs 2019+2
0 2021 0 vs 2020−3
5 2022 2022 5 vs 2021+5
1 2023 1 vs 2022−4
4 2024 2024 4 vs 2023+3
2 2025 2 vs 2024−2
1 2026 2026 to date 1
Latest Records Newest first across sources; each opens the record Date Record Source Dec 15, 2025 Untitled letter: COBENFY Office of Prescription Drug Promotion OPDP letters Sep 9, 2025 Untitled letter: Opdivo Qvantig Office of Prescription Drug Promotion OPDP letters Sep 9, 2025 Untitled letter: Opdivo and Yervoy Office of Prescription Drug Promotion OPDP letters Sep 9, 2025 Untitled letter: CAMZYOS Office of Prescription Drug Promotion OPDP letters Aug 1, 2024 Untitled letter: KRAZATI Office of Prescription Drug Promotion OPDP letters Jan 18, 2024 Warning letter: Drugs CDER Warning letters Oct 31, 2022 Warning letter: Aseptic processing, Sterility assurance, Out-of-specification CDER Warning letters Nov 2, 2012 ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59 Class II · CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other Drug recalls Jan 17, 2012 Complete response letter, NDA 202293 Approved Complete response letters Apr 8, 2004 CONVATEC FECAL MANAGEMENT SYSTEM K032734 · KNT 510(k) clearances Mar 26, 1999 DUODERM HYDROACTIVE GEL WOUND DRESSING K990368 · MGQ 510(k) clearances Sep 8, 1998 AQUACEL HYDROFIBER WOUND DRESSING K982116 · KMF 510(k) clearances Dec 29, 1997 DUODERM HYDROACTIVE GEL K973806 · MGQ 510(k) clearances Dec 23, 1997 DUODERM HYDROACTIVE PASTE K973807 · FRO 510(k) clearances Dec 17, 1997 DUODERM EXTRA THIN CGF DRESSING K973716 · FRO 510(k) clearances Dec 17, 1997 COMBIDERM ACD K973717 · FRO 510(k) clearances Apr 19, 1996 PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 K960949 · KNX 510(k) clearances
Subsidiaries and Divisions 13 firms in the Bristol-Myers Squibb group, most records first
SEC Filings Latest from BRISTOL MYERS SQUIBB CO; each opens the filing on EDGAR, where 8-K press releases are exhibit 99.1 Quarterly report 10-Q · Oct 29, 2026 Quarterly or annual results; press release or other announcement 8-K · Oct 29, 2026 Quarterly report 10-Q · Jul 30, 2026 Quarterly or annual results; press release or other announcement 8-K · Jul 30, 2026 Shareholder vote results 8-K · May 8, 2026 Quarterly report 10-Q · Apr 30, 2026 Quarterly or annual results; press release or other announcement 8-K · Apr 30, 2026 Proxy statement for the shareholder meeting DEF 14A · Mar 25, 2026 Annual report 10-K · Feb 11, 2026 Quarterly or annual results; press release or other announcement 8-K · Feb 5, 2026 Press release or other announcement 8-K · Jan 12, 2026 Press release or other announcement 8-K · Nov 18, 2025 Biologics Licensed by CBER One licence for vaccines, blood products and gene or cell therapies, which Drugs@FDA leaves out; see all CBER biologics Abecma Gene or cell therapy · Mar 3, 2021 Payments to Doctors (Open Payments) What 3 reporting entities in this group reported paying US doctors and teaching hospitals each year; see every company 2025: $471M General $55.2M · Research $416M 2024: $341M General $42.7M · Research $299M 2023: $321M General $41.2M · Research $280M 2022: $264M General $39.2M · Research $225M 2021: $263M General $28.2M · Research $234M 2020: $332M General $19.4M · Research $312M 2019: $350M General $41.8M · Research $308M State Antitrust Cases 2 multistate cases from state attorneys general naming this company; see all health-care cases Orphan Designations (FDA) 134 designations since 1983, 71 approved for the designated use, matched by the sponsor's name; see all orphan designations BCL6-LDD (B Cell Lymphoma 6 Ligand Directed Degrader) treatment of follicular lymphoma (FL) · Feb 13, 2026 (2M)-2-(4-(4-(aminomethyl)-1-oxo-1,2-dihydrophthalazin-6-yl)… treatment of pancreatic cancer · Nov 9, 2025 fetal hemoglobin activator cereblon (CRBN) E3 ligase-modulat… treatment of sickle cell disease · Jun 23, 2025 atigotatug plus nivolumab fixed dose combination treatment of small cell lung cancer · Mar 19, 2025 Augtyro Treatment of NTRK fusion-positive solid tumors · Mar 12, 2024 · approved Jun 13, 2024 2-[(3S)-2,6-dioxopiperidin-3-yl]-4-{[(2-fluoro-4-{[3-(morpho… Treatment of Follicular Lymphoma (FL) · Jan 25, 2023 luspatercept Treatment of Alpha-thalassemia · Sep 21, 2021 Vidaza Treatment of Juvenile myelomonocytic leukemia · Jul 28, 2021 · approved May 20, 2022 Medicines Authorised in the EU (EMA) 35 medicines, 27 of them new active substances, matched by the authorisation holder's name; see all EU approvals Augtyro New substance · repotrectinib · Jan 13, 2025 Krazati New substance · adagrasib · Jan 5, 2024 Camzyos New substance · mavacamten · Jun 26, 2023 Sotyktu New substance · deucravacitinib · Mar 24, 2023 Opdualag New substance · relatlimab;nivolumab · Sep 15, 2022 Breyanzi New substance · lisocabtagene maraleucel · Apr 4, 2022 Abecma New substance · idecabtagene vicleucel · Aug 18, 2021 Onureg New medicine · azacitidine · Jun 17, 2021 Approvals in Japan (PMDA) 44 approvals since 2008, 18 of them new active ingredients, matched by the Japanese company's name; see all Japanese approvals Augtyro Change · Repotrectinib · Nov 20, 2025 Yervoy Change · Ipilimumab (genetical recombination) · Aug 25, 2025 Inrebic New ingredient · Fedratinib hydrochloride hydrate · Jun 24, 2025 Yervoy Change · Ipilimumab (genetical recombination) · Jun 24, 2025 Camzyos New ingredient · Mavacamten · Mar 27, 2025 · Review report Revlimid Change · Lenalidomide hydrate · Feb 20, 2025 Zeposia New ingredient · Ozanimod hydrochloride · Dec 27, 2024 Augtyro New ingredient · Repotrectinib · Sep 24, 2024 · Review report Device Approvals in Japan (PMDA) One approval since 2007, 1 of them new devices, matched by the Japanese company's name; see all Japanese device approvals Aquacel Ag New device · Antimicrobial material · Oct 1, 2007
Canada and Imports Across the Bristol-Myers Squibb group, matched by company name FDA import refusals since 2024 31 shipment lines, through Oct 23, 2026
Names and Identifiers
Appears as BRISTOL MYERS SQUIBB Bristol-myers Squibb Company BRISTOL-MYERS SQUIBB Bristol-Myers Squibb Bristol-Myers Squibb Company Karuna Therapeutics, Inc., a Bristol Myers Squibb Co. Bristol Myers Squibb Mirati Therapeutics Inc., a Bristol Myers Squibb Co. Bristol-Meyers Squibb Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
