FDA, Covid and vaccines
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Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot,
Help Register Login Login Hi, %{firstName}% Hi, %{firstName}% Games Car rental The U.S. Food and Drug Administration (FDA) has officially approved a COVID-19 vaccine from Novavax for adults 65 and older and for individuals ages 12 to 64 who have an underlying health condition that puts them at higher risk for serious illness from a coronavirus infection.
The Trump administration shared the outlines of how it plans to push drug companies to lower their prices in the U.S.
The announcement, which followed the FDA setting new guidelines on COVID vaccine approvals, erased the stock’s gains from yesterday.
Moderna filed for FDA approval of its mRNA-1083 combination shot last year. The submission put the biotech on track to win approval in adults aged 50 and older in November 2025. However, at the start of May, Moderna pushed back the expected approval date to 2026 after the FDA asked to see phase 3 efficacy before making a decision on authorization.
The rollout of updated Covid vaccines for healthy children and adults this fall is likely to be delayed after the FDA said it will require another clinical trial.
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Live Science on MSN2-in-1 COVID-flu vaccine looks promising in trial — but experts say approval may be delayedLate-stage trial data suggest that a new COVID-flu vaccine offers good protection against both infections, but experts expect the shot's approval may be delayed.
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MySuncoast.com on MSNNew Novavax Covid -19 vaccine tailored for patients 65 and olderAfter a six-week long delay, The Food and Drug Administration (FDA) has finally approved a more traditional protein-based covid vaccine produced by pharmaceutical giant Novavax.