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Covid-19, Novavax and US FDA

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.

The Wall Street Journal on MSN · 2d

FDA Asks Vaccine Maker to Complete New Clinical Trial for Delayed Covid-19 Shot

Federal regulators are asking Novavax to complete an additional randomized clinical trial on its Covid-19 vaccine after previously delaying approval, people familiar with the matter said, a request that could be so prohibitively expensive the company might not be able to fulfill it.

Reuters on MSN · 2d

US FDA asks Novavax to complete new clinical trial for delayed COVID-19 shot, WSJ reports

(Reuters) -Federal regulators have asked Novavax to complete an additional clinical trial on its COVID-19 vaccine after previously delaying approval, the Wall Street Journal reported on Friday, citing people familiar with the matter.

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 ...

42m

Novavax: Grandiose Ambitions, Smart Strategy, But FDA Decision Adds To Challenges

Novavax shows financial improvement but faces vaccine challenges. Read why I rated NVAX stock as 'Hold' and what risks and ...

3d

Claims That the FDA Has Approved Ivermectin to Treat COVID-19 Are False

At the peak of the COVID-19 pandemic, many vaccine skeptics turned to ivermectin, a medication proven to fight off parasitic ...

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.

2don MSN

FDA chief says no current plans to restrict mifepristone access

Commissioner Marty Makary said he has no plans to change current policy to restrict access to the abortion pill mifepristone, ...

4d

RFK Jr. could pull Covid vax for kids

HHS Secretary Robert F. Kennedy Jr. is mulling removing the Covid-19 vaccine from the recommended childhood vaccine schedule.

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