United States — Food and Drug Administration & Bristol Myers Squibb
5 shared events · Importance 3 · Last updated Aug 18, 2026
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Regulatory
United States — Food and Drug Administration: The FDA rejected Replimune's BLA and published briefing documents raising concerns about the data package, triggering the stock drop and subsequent lawsuits. The FDA's actions are central to the event.
Bristol Myers Squibb: Bristol Myers Squibb's drug Opdivo is part of the combination therapy in Replimune's BLA. The rejection may have minor negative implications for BMS, but it is not a primary defendant.
Jul 29, 2026 · 65 articles
Business
United States — Food and Drug Administration: The US FDA provides supportive regulatory frameworks that facilitate product approvals and market growth in North America.
Bristol Myers Squibb: Bristol Myers Squibb is a key player in the antibody therapeutics market, benefiting from the projected market growth.
Jul 28, 2026 · 6 articles
Business
United States — Food and Drug Administration: The FDA declined to approve Lantheus' LNTH-2501 application due to manufacturing issues, a setback for Lantheus' pipeline.
Bristol Myers Squibb: Bristol Myers Squibb is mentioned as a prior acquirer in the sector, highlighting the trend of radiopharmaceutical consolidation.
Aug 03, 2026 · 7 articles
Tech
Bristol Myers Squibb: Bristol Myers Squibb is jointly developing pumitamig with BioNTech, which is being used in the clinical trial collaboration with Boehringer Ingelheim.
Apr 09, 2026 · 6 articles
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