FDA approved Novavax's Nuvaxovid BLA, leading to Sanofi receiving a milestone payment and taking over U.S. commercial leadership.
9 reports, 6 independent
Updated Aug 28
Gone quiet
Reached 6 outlets in its first 24 hours
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- 9
- Developments
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- Repetition
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New informationRepeats or wire copies
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What happened
FDA approved Novavax's Nuvaxovid BLA, leading to Sanofi receiving a milestone payment and taking over U.S. commercial leadership.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.- Novavax and Sanofi announced a partnership to facilitate vaccine access.Sub-event
Novavax received FDA approval for Nuvaxovid, and leadership of U.S. commercial operations transferred to Sanofi.1 source
RFK Jr.'s policy shift led to project cancellations as Novavax transitioned Nuvaxovid leadership to Sanofi.1 source
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The entities involved
- FDA
-
Novavax
company in Gaithersburg, Maryland
Nothing else this week.
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Sanofi
company in Milan, Italy
Nothing else this week.
Related events
- On August 28, 2026, the FDA approved Moderna's mNEXSPIKE vaccine and gave the green light to Novavax's Nuvaxovid vaccine. Separately, ProFound Therapeutics was formed by Flagship Pioneering.
- A supply deal for NUBEQA was finalized between ORIC Pharmaceuticals and BAYER after talks with the FDA.
- Sarclisa receives EMA approval for multiple myeloma, Sanofi develops new treatments, and Trump-era tariffs benefit AI stocks.
- Acurx Pharmaceuticals trades on NASDAQ and is receiving FDA guidance supporting its potential approval pathway.
- Ionis Pharmaceuticals is seeking FDA approval for its treatments for Alexander disease, including Tryngolza, and has formed new partnerships with AstraZeneca and Hoffmann-La Roche.
Coverage
Newest first; wire copies grouped- Insider MonkeyNovavax, Inc. (NVAX) Wins FDA Approval for Nuvaxovid BLA We recently compiled a list of the 11 Cheap Biotech Stocks to Buy According to Hedge Funds. Novavax, Inc. is one of them. Novavax, Inc. (NASDA
- Simply Wall St.Novavax (NVAX) Is Up After FDA Approves Updated Nuvaxovid for Key High-Risk Groups—What's Changed On August 27, 2025, Novavax announced that the U.S. FDA approved the Nuvaxovid 2025-2026 COVID-19 vac
- Insider MonkeyNovavax, Inc. (NVAX) Launches Protein-Based Vaccine for High-Risk Adults We recently published 10 Best Biotech Stocks to Buy Under $10. Novavax, Inc. is one of them. Novavax, Inc. (NASDAQ:NVAX) is a
- ZacksNVAX Stock Gains on Q2 Earnings & Sales Beat, Ups '25 Sales View Novavax NVAX reported second-quarter 2025 earnings per share (EPS) of 62 cents against the Zacks Consensus Estimate of a loss of seven
- Investing.comNovavax lifts 2025 revenue outlook after FDA milestone payment Investing.com -- Novavax on Wednesday raised its full-year revenue forecast as it received a $175 million milestone payment from Sanofi
- BenzingaNovavax Ups Outlook, Eyes Stronger Nuvaxovid Sales On Wednesday, Novavax Inc. (NASDAQ:NVAX) reported second-quarter 2025 sales of $239.24 million, compared to $415 million a year ago, beating the con
- PR NewswireNovavax Reports Second Quarter 2025 Financial Results and Operational Highlights Total revenue of $239 million in the second quarter of 2025 Received FDA BLA approval for Nuvaxovid™, the only recombi