United States — Food and Drug Administration & Sanofi
9 shared events · Importance 3 · Last updated Aug 07, 2026
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Business
United States — Food and Drug Administration: The United States — Food and Drug Administration granted priority review to Sanofi's venglustat, indicating its potential to address an unmet medical need for type 3 Gaucher disease.
Sanofi: Sanofi has received priority review for its drug venglustat, which could significantly expand its portfolio in lysosomal storage diseases and provide a new revenue stream if approved.
May 28, 2026 · 6 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.
Sanofi: Sanofi's high-dose flu vaccine served as a comparator in trials; the new mRNA vaccine may compete with its products.
Aug 05, 2026 · 105 articles
Business
United States — Food and Drug Administration: The US FDA provides supportive regulatory frameworks that facilitate product approvals and market growth in North America.
Sanofi: Sanofi is a key player in the antibody therapeutics market, benefiting from the projected market growth.
Jul 28, 2026 · 6 articles
Regulatory
United States — Food and Drug Administration: Regulatory body that approved Lipfendra, enabling market entry.
Sanofi: Co-marketer of Praluent; faces similar competitive pressure.
Jul 16, 2026 · 93 articles
Regulatory
United States — Food and Drug Administration: The FDA's regulatory decisions are the subject of some of Kalshi's new contracts.
Sanofi: Sanofi is one of the companies whose drug approvals are being bet on, but is not directly involved.
Jul 16, 2026 · 7 articles
Business
United States — Food and Drug Administration: Granted Fast Track and Breakthrough Therapy designations to lacutamab, facilitating its development and review.
Sanofi: Mentioned as a collaborator with Innate, not directly involved in this partnership.
Aug 10, 2026 · 10 articles
Business
Sanofi: Sanofi, in collaboration with Regeneron Pharmaceuticals, developed Dupixent and received International — European Commission approval for its use in treating chronic spontaneous urticaria in young children, which is expected to boost its market position and revenue.
Apr 13, 2026 · 8 articles
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