United States — Food and Drug Administration & Eli Lilly and Company
18 shared events · Importance 3 · Last updated Aug 24, 2026
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Regulatory
United States — Food and Drug Administration: The FDA granted clearance to the Elecsys pTau217 blood test, a regulatory action that enables U.S. marketing and use of the test.
Eli Lilly and Company: Eli Lilly partnered with Roche in developing the test and will benefit from royalties or shared revenue, strengthening its presence in Alzheimer's diagnostics.
Aug 24, 2026 · 7 articles
Regulatory
United States — Food and Drug Administration: The FDA has stated that unapproved retatrutide sales are illegal and cannot be compounded. Lilly has referred over 200 entities to the FDA and delayed its submission to Q1 2027, making the agency central to the regulatory environment.
Eli Lilly and Company: Eli Lilly is the plaintiff, filing six lawsuits and escalating its campaign against unauthorized sellers of retatrutide. The company also delayed its FDA submission to Q1 2027 and allowed limited early access, reflecting both legal and regulatory actions that protect its pipeline and market position.
Aug 12, 2026 · 6 articles
Regulatory
United States — Food and Drug Administration: The FDA has been cracking down on compounded GLP-1s; the study supports the need for further regulatory action.
Eli Lilly and Company: Eli Lilly's Zepbound is another GLP-1 drug involved; the study could prompt regulatory actions that impact its distribution.
Jul 07, 2026 · 6 articles
Tech
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> granted Fast Track designation to VERVE-102, indicating its recognition of the therapy's potential to address an unmet medical need.
Eli Lilly and Company: As the parent company of Verve PCSK9-inhibitor gene therapy>>>, Eli Lilly and Company>>> is a key developer of VERVE-102, a gene-editing therapy that has shown promising results in lowering cholesterol. This breakthrough could significantly impact its future market position in cardiovascular medicine.
May 26, 2026 · 12 articles
Domestic
United States — Food and Drug Administration: The United States — Food and Drug Administration approved Eli Lilly and Company's weight loss pill, Foundayo, impacting the pharmaceutical market.
Eli Lilly and Company: Eli Lilly and Company rose after the United States — Food and Drug Administration approved its new weight loss pill, Foundayo.
Apr 01, 2026 · 14 articles
Business
United States — Food and Drug Administration: The FDA granted Breakthrough Therapy Designation to BPL-003 and announced regulatory actions to support psychedelic drug development, facilitating the path to market.
Eli Lilly and Company: Eli Lilly is the acquirer, paying $2.8B upfront for Atai Life Sciences to bolster its neuroscience pipeline and diversify beyond its weight-loss drug franchise. The deal is part of a broader acquisition spree funded by strong commercial performance.
Jul 16, 2026 · 25 articles
Business
United States — Food and Drug Administration: The Taiwan FDA granted marketing approval for QUVIVIQ, a regulatory milestone that enables commercialization in Taiwan.
Eli Lilly and Company: Eli Lilly completed its acquisition of KC Pharmaceuticals, strengthening its sleep disorder portfolio. Nxera retains rights to future milestone and royalty payments from the orexin programs, benefiting Lilly's pipeline.
Aug 07, 2026 · 6 articles
Business
United States — Food and Drug Administration: The United States — Food and Drug Administration previously approved a biologic incorporating Hanmi Pharm. Co., Ltd.'s LAPSCOVERY platform, indicating a regulatory pathway for similar drugs.
Eli Lilly and Company: Eli Lilly and Company obtained exclusive worldwide rights (excluding Korea) to develop, manufacture, and commercialize sonefpeglutide, expanding its pipeline in areas like short bowel syndrome and other indications, potentially leading to new revenue streams.
Jun 01, 2026 · 11 articles
Regulatory
United States — Food and Drug Administration: The FDA's roadmap favoring non-animal testing methods is mentioned as a potential growth driver for VivoSim's business.
Eli Lilly and Company: Eli Lilly made a $5.0 million milestone payment to VivoSim related to the FXR program sale, a routine contractual obligation.
Aug 06, 2026 · 6 articles
Regulatory
United States — Food and Drug Administration: The FDA's regulatory decisions are the subject of some of Kalshi's new contracts.
Eli Lilly and Company: Eli Lilly is mentioned as the former employer of Alpheus Bingham, who helped build an internal prediction market.
Jul 16, 2026 · 7 articles
Business
United States — Food and Drug Administration: The United States — Food and Drug Administration has cleared the CareMiBrain system for use and has approved new monoclonal antibody treatments for Alzheimer's Disease, creating a market for the PET scans.
Eli Lilly and Company: Eli Lilly and Company developed Kisunla, one of the FDA-approved monoclonal antibody treatments for Alzheimer's Disease, which requires a positive beta-amyloid brain scan.
Jul 06, 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.
Eli Lilly and Company: Eli Lilly is mentioned as a prior acquirer of Point Biopharma and as a former partner with Lantheus on a PSMA-directed therapeutic that was abandoned after an unfavorable trial.
Aug 03, 2026 · 7 articles
Business
United States — Food and Drug Administration: The United States — Food and Drug Administration has granted various designations to MiNK Therapeutics' programs and is involved in the approval pathway for its Fabry gene therapy.
Eli Lilly and Company: Eli Lilly and Company has licensed MiNK Therapeutics' STAC-BBB platform for neurological targets, indicating a past business relationship that could be affected by Sangamo's strategic review.
Jun 08, 2026 · 7 articles
Business
Eli Lilly and Company: Eli Lilly and Company faces increased competition with Novo Nordisk's Wegovy pill launch, potentially impacting its market dominance in weight-loss drugs. Its shares fell following the announcement.
Jan 05, 2026 · 7 articles
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Eli Lilly and Company delayed FDA submission United States — Food and Drug AdministrationLilly sues six over...
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Eli Lilly and Company referred to regulators United States — Food and Drug AdministrationLilly sues six over...
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