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GSK earns FDA approval for Jideytro

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GSK earns FDA approval for Jideytro

16 sourcesUpdated Jul 23, 20261 min read

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GSK earns FDA approval for Jideytro — © IJR

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GSK secured FDA approval for Jideytro (zidesamtinib), its first lung cancer medicine, for ROS1-positive NSCLC after prior ROS1 inhibitor treatment. The approval, based on ARROS-1 trial data showing a 44% objective response rate, came ahead of the September 18 target date. Jideytro is part of GSK’s $10.6 billion acquisition of Nuvalent, fueling its push to expand its oncology portfolio. The drug is a next-generation ROS1 inhibitor designed to be selective and to cross the blood-brain barrier to address brain metastases and resistance mutations. It will compete with existing ROS1 therapies like Xalkori and Rozlytrek and faces sales uncertainty in a competitive market. GSK's leadership positions this approval as a milestone in rebuilding its cancer drug business under CEO Luke Miels, with further Nuvalent assets progressing, including neladalkib.

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FDA Requires GLP-1 Warnings on Potential Blindness Risk

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Last updatedJul 23, 2026

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Broke uk.advfn.com · Jul 22, 12:22 PM ETCenter within the hourRight +2h9 sources +6h on

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“$10B M&A Deal Pays Off With GSK’s First Lung Cancer Drug Approval - MedCity News”

MedCity News · Jul 22, 2026

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“GSK wins FDA nod for Jideytro lung cancer drug (GSK:NYSE)”

Seeking Alpha · Jul 22, 2026

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The FDA is requiring makers of GLP-1 drugs, including Ozempic, Wegovy, Mounjaro and Zepbound, to warn patients and clinicians about a possible risk of NAION, a rare condition caused by reduced blood flow to the optic nerve. The condition can cause sudden vision loss and, in severe cases, permanent blindness.

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