United States — Food and Drug Administration & AstraZeneca
13 shared events · Importance 3 · Last updated Aug 07, 2026
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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.
AstraZeneca: AstraZeneca's flu vaccine portfolio could be affected by the entry of mFLUSIVA.
Aug 05, 2026 · 105 articles
Regulatory
United States — Food and Drug Administration: The USFDA granted tentative approval for the ANDA, a routine regulatory action for generic drugs. The agency's role is procedural.
AstraZeneca: AstraZeneca's Lynparza faces generic competition if the tentative approval leads to final launch. The ongoing Paragraph IV litigation may delay market entry.
Jul 19, 2026 · 6 articles
Business
United States — Food and Drug Administration: FDA received sNDA for first-line Zegfrovy and granted Breakthrough Therapy Designation.
AstraZeneca: AstraZeneca expands its lung cancer portfolio with a novel oral EGFR inhibitor, complementing existing drugs like Tagrisso. The deal involves a $600M upfront payment and potential milestones, but does not affect 2026 guidance.
Jul 14, 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>>>.
AstraZeneca: AstraZeneca>>> is mentioned as a rival to GSK plc>>> in the oncology market, highlighting GSK plc>>>'s ambition to increase its share of income from cancer medicines.
Jun 09, 2026 · 56 articles
Accidents
United States — Food and Drug Administration: The United States — Food and Drug Administration has approved Inmazeb, a combination of antibodies, to treat Zaire Ebolavirus infection, which Regeneron Pharmaceuticals has donated for potential use in the current outbreak.
AstraZeneca: AstraZeneca was involved in the development of the COVID-19 vaccine platform that is now being considered for a Bundibugyo ebolavirus vaccine, showcasing its role in vaccine innovation.
May 18, 2026 · 505 articles
Business
United States — Food and Drug Administration: Granted Fast Track and Breakthrough Therapy designations to lacutamab, facilitating its development and review.
AstraZeneca: Collaborator with Innate on monalizumab, mentioned as part of Innate's partnered assets, not directly affected by this deal.
Aug 10, 2026 · 10 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.
AstraZeneca: AstraZeneca is mentioned as a prior acquirer of KC Pharmaceuticals, illustrating sector M&A activity.
Aug 03, 2026 · 7 articles
Business
United States — Food and Drug Administration: No FDA-approved treatments exist for CACS, highlighting unmet need.
AstraZeneca: AstraZeneca originally developed ART27.13 but is not directly involved in this event.
Jul 13, 2026 · 7 articles
Business
United States — Food and Drug Administration: The FDA has cleared several of Ascentage Pharma's Phase III trials, but this event does not directly involve the FDA.
AstraZeneca: AstraZeneca is a partner of Ascentage Pharma, but this event does not directly involve AstraZeneca.
Jul 26, 2026 · 6 articles
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