United States — Food and Drug Administration & GSK plc
11 shared events · Importance 3 · Last updated Aug 13, 2026
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Regulatory
United States — Food and Drug Administration: The FDA granted accelerated approval for Jideytro, marking a regulatory milestone for the agency in oncology.
GSK plc: GSK received FDA approval for its first lung cancer drug Jideytro, enhancing its oncology portfolio and potentially driving future revenue growth.
Jul 22, 2026 · 6 articles
Tech
United States — Food and Drug Administration: The United States — Food and Drug Administration is currently reviewing bepirovirsen for fast-track approval, and its decision in October will be crucial for the drug's market entry in the United States.
GSK plc: As a developer and funder of bepirovirsen, GSK plc stands to benefit significantly from the drug's potential approval and market success, enhancing its reputation and financial outlook in the pharmaceutical industry.
May 28, 2026 · 8 articles
Business
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> is currently reviewing two of GSK plc>>>'s experimental lung cancer treatments for approval, which are key assets in the acquisition by GSK plc>>>.
GSK plc: GSK plc>>> is being acquired by GSK plc>>> for $10.6 billion, representing a 40% premium to its last closing price. This acquisition validates GSK plc>>>'s innovative work in developing targeted cancer therapies, particularly for lung cancer, and provides its shareholders with significant value.
Jun 09, 2026 · 56 articles
Regulatory
United States — Food and Drug Administration: The FDA granted approval for mFLUSIVA, marking a regulatory milestone and demonstrating its role in vaccine oversight despite internal controversies.
GSK plc: GSK plc's flu vaccines face potential competition from mFLUSIVA.
Aug 05, 2026 · 105 articles
Domestic
United States — Food and Drug Administration: Responsible for approving any new separate vaccines, a process that could take years. It faces pressure to review unbundled shots without precedent.
GSK plc: Another vaccine manufacturer, it also criticized the order and faces potential business implications if separate vaccines are developed.
Aug 10, 2026 · 235 articles
Domestic
United States — Food and Drug Administration: The United States — Food and Drug Administration was directed by Donald Trump to issue new guidance on acetaminophen and approved leucovorin for autism treatment, facing scrutiny for its scientific basis.
GSK plc: GSK plc, as the manufacturer of Wellcovorin (a branded version of leucovorin), was asked by the United States — Food and Drug Administration to file a new application with data on cerebral folate deficiency.
Sep 22, 2025 · 6 articles
Business
United States — Food and Drug Administration: The FDA approved Palsonify in 2025, enabling its commercial availability. The agency's regulatory decisions are relevant to the value of the acquired assets.
GSK plc: Mentioned as part of 2026 M&A activity; acquired GSK plc for $10.6B.
Jul 06, 2026 · 34 articles
Business
United States — Food and Drug Administration: The United States — Food and Drug Administration approved NUZOLVENCE, one of Innoviva's products.
GSK plc: GSK plc is a partner of Innoviva, from whom Innoviva receives royalties on sales of respiratory assets.
Jun 01, 2026 · 6 articles
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