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Bristol Myers Squibb (BMY) FDA Events

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FDA Events for Bristol Myers Squibb (BMY)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Bristol Myers Squibb (BMY). Over the past two years, Bristol Myers Squibb has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Abecma, Breyanzi, CAMZYOS®, CheckMate, CheckMate, COBENFY, and Deucravacitinib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Bristol Myers Squibb's Drugs in FDA Review

Abecma (idecabtagene vicleucel) - FDA Regulatory Timeline and Events

Abecma (idecabtagene vicleucel) is a drug developed by Bristol Myers Squibb for the following indication: Relapsed and Refractory Multiple Myeloma. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Breyanzi (lisocabtagene maraleucel) - FDA Regulatory Timeline and Events

Breyanzi (lisocabtagene maraleucel) is a drug developed by Bristol Myers Squibb for the following indication: Second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

CAMZYOS® (mavacamten) - FDA Regulatory Timeline and Events

CAMZYOS® (mavacamten) is a drug developed by Bristol Myers Squibb for the following indication: For the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

CheckMate -067 - FDA Regulatory Timeline and Events

CheckMate -067 is a drug developed by Bristol Myers Squibb for the following indication: In Advanced Melanoma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

CheckMate -73L - FDA Regulatory Timeline and Events

CheckMate -73L is a drug developed by Bristol Myers Squibb for the following indication: in untreated, locally advanced stage III non-small cell lung cancer (NSCLC) that are not intended or eligible for curative surgery. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

COBENFY - FDA Regulatory Timeline and Events

COBENFY is a drug developed by Bristol Myers Squibb for the following indication: For the Treatment of Schizophrenia in Adults. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Deucravacitinib - FDA Regulatory Timeline and Events

Deucravacitinib is a drug developed by Bristol Myers Squibb for the following indication: Moderate to severe plaque psoriasis. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KarXT (xanomeline-trospium) - FDA Regulatory Timeline and Events

KarXT (xanomeline-trospium) is a drug developed by Bristol Myers Squibb for the following indication: Healthy Elderly Volunteers. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KRAZATI (adagrasib) - FDA Regulatory Timeline and Events

KRAZATI (adagrasib) is a drug developed by Bristol Myers Squibb for the following indication: for the treatment of patients with previously treated KRASG12C. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Lenalidomide Capsules - FDA Regulatory Timeline and Events

Lenalidomide Capsules is a drug developed by Bristol Myers Squibb for the following indication: Multiple myeloma and myelodysplastic syndrome. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Mavacamten - FDA Regulatory Timeline and Events

Mavacamten is a drug developed by Bristol Myers Squibb for the following indication: Symptomatic obstructive hypertrophic cardiomyopathy (oHCM). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Opdivo (nivolumab) - FDA Regulatory Timeline and Events

Opdivo (nivolumab) is a drug developed by Bristol Myers Squibb for the following indication: Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Opdivo (Nivolumab) + Yervoy (Ipilimumab) CheckMate-743 - FDA Regulatory Timeline and Events

Opdivo (Nivolumab) + Yervoy (Ipilimumab) CheckMate-743 is a drug developed by Bristol Myers Squibb for the following indication: Unresectable Malignant Pleural Mesothelioma. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Opdivo®(nivolumab) plus Yervoy®(ipilimumab) CheckMate -9DW - FDA Regulatory Timeline and Events

Opdivo®(nivolumab) plus Yervoy®(ipilimumab) CheckMate -9DW is a drug developed by Bristol Myers Squibb for the following indication: for the First-Line Treatment of Adult Patients with Unresectable or Advanced Hepatocellular Carcinoma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Opdualag - FDA Regulatory Timeline and Events

Opdualag is a drug developed by Bristol Myers Squibb for the following indication: For the adjuvant treatment of patients with completely resected stage III-IV melanoma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Repotrectinib - FDA Regulatory Timeline and Events

Repotrectinib is a drug developed by Bristol Myers Squibb for the following indication: NTRK Fusion-Positive Advanced Solid Tumors. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Zeposia (Ozanimod) - FDA Regulatory Timeline and Events

Zeposia (Ozanimod) is a drug developed by Bristol Myers Squibb for the following indication: Active Ulcerative Colitis (UC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Bristol Myers Squibb FDA Events - Frequently Asked Questions

Yes, Bristol Myers Squibb (BMY) has received FDA approval for multiple therapies, including Opdivo (Nivolumab) + Yervoy (Ipilimumab) CheckMate-743, Opdivo (nivolumab), KarXT (xanomeline-trospium), COBENFY, Repotrectinib and Abecma (idecabtagene vicleucel). This page tracks recent and historical FDA regulatory events related to Bristol Myers Squibb's drug portfolio.

In the past two years, Bristol Myers Squibb (BMY) has reported FDA regulatory activity for the following drugs: Opdivo (nivolumab), Breyanzi (lisocabtagene maraleucel), Deucravacitinib, Opdivo (Nivolumab) + Yervoy (Ipilimumab) CheckMate-743, Repotrectinib, KarXT (xanomeline-trospium), KRAZATI (adagrasib), COBENFY, Abecma (idecabtagene vicleucel), CAMZYOS® (mavacamten), Mavacamten, Opdivo®(nivolumab) plus Yervoy®(ipilimumab) CheckMate -9DW, Lenalidomide Capsules, Opdualag, Zeposia (Ozanimod), CheckMate -067 and CheckMate -73L.

The most recent FDA-related event for Bristol Myers Squibb occurred on June 26, 2025, involving Breyanzi (lisocabtagene maraleucel). The update was categorized as "FDA approved," with the company reporting: "Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved label updates for both of its CAR T cell therapies, Breyanzi® (lisocabtagene maraleucel; liso-cel) for the treatment of large B cell lymphoma (LBCL) and other lymphomas and Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of multiple myeloma."

Current therapies from Bristol Myers Squibb in review with the FDA target conditions such as:

  • Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting - Opdivo (nivolumab)
  • Second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL) - Breyanzi (lisocabtagene maraleucel)
  • Moderate to severe plaque psoriasis - Deucravacitinib
  • Unresectable Malignant Pleural Mesothelioma - Opdivo (Nivolumab) + Yervoy (Ipilimumab) CheckMate-743
  • NTRK Fusion-Positive Advanced Solid Tumors - Repotrectinib
  • Healthy Elderly Volunteers - KarXT (xanomeline-trospium)
  • for the treatment of patients with previously treated KRASG12C - KRAZATI (adagrasib)
  • For the Treatment of Schizophrenia in Adults - COBENFY
  • Relapsed and Refractory Multiple Myeloma - Abecma (idecabtagene vicleucel)
  • For the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy - CAMZYOS® (mavacamten)
  • Symptomatic obstructive hypertrophic cardiomyopathy (oHCM) - Mavacamten
  • for the First-Line Treatment of Adult Patients with Unresectable or Advanced Hepatocellular Carcinoma - Opdivo®(nivolumab) plus Yervoy®(ipilimumab) CheckMate -9DW
  • Multiple myeloma and myelodysplastic syndrome - Lenalidomide Capsules
  • For the adjuvant treatment of patients with completely resected stage III-IV melanoma - Opdualag
  • Active Ulcerative Colitis (UC) - Zeposia (Ozanimod)
  • In Advanced Melanoma - CheckMate -067
  • in untreated, locally advanced stage III non-small cell lung cancer (NSCLC) that are not intended or eligible for curative surgery. - CheckMate -73L

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NYSE:BMY) was last updated on 7/10/2025 by MarketBeat.com Staff
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