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Covid-19, FDA and Novavax

CNN on MSN · 4h

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 · 11h

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 · 9h

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

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.

13hon 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, ...

3don MSN

RFK Jr. eyes reversing CDC’s Covid-19 vaccine recommendation for children

Just 13 percent of children have gotten the latest Covid shot, according to the most recent CDC data. And after Republicans, ...

New FDA Chief Martin Makary Says DOGE Cuts Haven’t Hit Science Staff

The new FDA chief reiterated his commitment to speeding up drug approval processes and run the agency by “gold standard ...

FDA Commissioner Marty Makary announces three new hires in leadership team

The commissioner of the FDA welcomed three new leaders to the agency this week, including a new deputy commissioner.

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