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US FDA orders new eye risk warnings for Ozempic, Zepbound
Why it’s here: FDA is requiring label changes (a federal regulatory action) for major GLP-1 drugs over a newly flagged safety risk, which is a US federal regulatory development with policy implications for drug regulation and the sector.
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6d agoYahooUS FDA orders new eye risk warnings for Ozempic, ZepboundThe FDA ordered GLP-1 weight-loss and diabetes drugs such as Zepbound, Mounjaro, Ozempic and Wegovy to add a potential eye-risk warning (NAION) to their labeling.1 outletBiotech6 linked
Connected
6 links- NewsSTAT+: FDA warns GLP-1 drugs carry potential risk of rare eye conditionBoth involve Food and Drug Administration, GLP-1 drugs
- NewsFDA warns against online weight-loss drugs containing uncertain ingredientsBoth involve Food and Drug Administration
- HillComments due: Evaluating Benefit-Risk in Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities: Discussion Paper and Request for FeedbackBoth involve Food and Drug Administration
- HillComments due: Robotically-Assisted Surgical Devices - Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Draft GuidanceBoth involve Food and Drug Administration
- NewsSTAT+: GLP-1s are given an FDA warning for rare eye condition riskBoth involve Food and Drug Administration
- HillComments due: Public Workshop: Evaluating Benefit-Risk in Robotic Medical Devices with Autonomous or Remote Teleoperation CapabilitiesBoth involve Food and Drug Administration
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- Food and Drug Administration