US Drug Regulator Delays Novavax Covid Vaccine Approval [Barron's]
Novavax, Inc. (NVAX)
Last novavax, inc. earnings: 3/11 04:17 pm
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Source: Barrons
In a document sent to the financial markets regulator and seen by AFP, US drugmaker Novavax said it was still awaiting a response from the Food and Drug Administration (FDA), which had been promised to make a decision by April 1. "As of Tuesday, April 1, we had responded to all of the FDA's information requests," Novavax said in the filing, adding it believes its vaccine is ready for approval. "As of today, we continue to wait on action from the agency and have not yet received an official decision from the US FDA," it added. The company is seeking full approval of its Covid-19 vaccine, which is already authorized in the United States through an emergency use procedure for people aged 12 and over. According to the Wall Street Journal, which first reported the delay, the authorization is being blocked by FDA officials, who are reportedly requesting "more data." Politico described the action as a "a highly unusual step." Contacted by AFP, the FDA did not immediately respond
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- New Report Urges Action to Ensure Sustainable, Affordable Supply of Key Vaccine Adjuvants for Global Health Use [Yahoo! Finance]Yahoo! Finance
- Why I Wouldn't Touch Novavax With a 10-Foot Pole [Yahoo! Finance]Yahoo! Finance
- Novavax (NASDAQ:NVAX) had its "sell (d)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Novavax, Inc. (NVAX): A Bull Case Theory [Yahoo! Finance]Yahoo! Finance
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- 11/6/25 - Miss
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Sec Filings
- 12/15/25 - Form 4
- 11/12/25 - Form SCHEDULE
- 11/6/25 - Form 8-K
- NVAX's page on the SEC website