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New COVID-19 Vaccine on Track for FDA Approval

CNN on MSN · 1d

FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval

The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 vaccine as a post-approval commitment, a source familiar with the matter told CNN.

Novavax COVID Vaccine Moves Closer to Full FDA Approval

Under emergency use, vaccines can be removed even after a health emergency is considered to be over. Full approval from the FDA means a product can stay on the market even after a health emergency ends. (The World Health Organization declared an end to the COVID emergency in May 2023.)

Bloomberg on MSN · 2d

Novavax Falls on Report That FDA Wants New Covid Vaccine Trial

Novavax Inc. shares fell after the Wall Street Journal reported that US regulators asked the company to conduct another clinical trial of its Covid vaccine.

5h

FDA’s job cuts paint mixed picture for drugmaker’s R&D plans

After a 20% cut to the FDA’s workforce, biotechs and pharmas are bracing for delays. But the impacts won’t be consistent.

U.S. health officials inject new uncertainty into approval process for Covid boosters

Confusion over the FDA delay in granting full approval to Novavax’s Covid-19 vaccine deepened over the weekend, with possible ...

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