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Sep 2, 2026Weekly roundup2 fact check notes

BMS logs three FDA label approvals and posts results for melanoma combo trial

Bristol-Myers Squibb received three FDA labeling supplement approvals, posted results for an investigator-led melanoma trial, and registered a new pharmacokinetic study.

Bristol-Myers Squibb had a full slate of regulatory and trial activity, spanning posted trial results, three FDA label approvals, and a newly registered Phase 1 study.

  • An investigator-sponsored Phase II trial combining nivolumab (BMS-936558) and relatlimab (BMS-986016) in melanoma patients naive to immunotherapy posted results, with the registry listing John Kirkwood as lead sponsor and Bristol-Myers Squibb as a collaborator1. The trial enrolled 43 participants1.
  • The FDA approved a labeling supplement for YERVOY (ipilimumab, BLA125377, SUPPL 140), with a submission status date of August 31, 2026. Filing records show an approval letter dated September 2, 2026 and a revised label dated September 1, 20262.
  • The FDA approved a REMS-related supplement for THALOMID (thalidomide, NDA020785, SUPPL 74), with a submission status date of September 2, 2026. Documents list an approval letter and medication guide both dated September 4, 2026, and a revised label dated September 8, 20263.
  • The FDA approved a labeling supplement for KRAZATI (adagrasib, NDA216340, SUPPL 11), with a submission status date of September 1, 2026. The approval letter is dated September 2, 2026 and the revised label is dated September 8, 20264.
  • A new Phase 1 pharmacokinetic study, "A Study of Navlimetostat (BMS-986504) Drug Interactions and Food Effect in Healthy Participants" (NCT07800897), was listed as not yet recruiting when first posted on September 2, 20265, with an estimated start date of August 26, 2026 and planned enrollment of 80 participants5 to evaluate food effect and drug interactions affecting Navlimetostat levels in healthy adult female participants5.

Fact check notes

  • ImpreciseBristol-Myers Squibb received three FDA labeling supplement approvalsTwo of the three (YERVOY, KRAZATI) are 'Labeling' submission_class, but THALOMID's submission_class is 'REMS', not 'Labeling'. Calling all three 'labeling supplement approvals' is imprecise, though the entry later correctly identifies THALOMID as REMS-related.
  • Checker's noteThe summary sentence describes all three FDA supplements as 'labeling supplement approvals,' but THALOMID's submission_class is listed as 'REMS', not 'Labeling' (only YERVOY and KRAZATI are classified as Labeling). The entry does correctly note THALOMID as 'REMS-related' in its own bullet, creating a minor inconsistency with the overarching summary line.

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Where the check questioned a sentence, its note is shown above. Not investment advice.