FDA, COVID-19 and vaccination
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FDA leaders say the agency will require more clinical trials to show the benefits of annual COVID shots for healthy adults.
The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at higher risk of severe disease, but will require vaccine makers to conduct major new clinical trials before approving them for wider use.
The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded warning labels with more information about the risk of a rare heart condition after vaccination.
In this week’s edition of InnovationRx, we look at the FDA's new rules on Covid-19 vaccines, Novartis’s acquisition strategy, Medtronic’s diabetes spinoff, Regeneron’s purchase of 23AndMe, and more.
The FDA is requiring COVID vaccine makers Pfizer and Moderna to update their warnings about the possible risk of myocarditis and pericarditis.
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Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate after discussions with the U.S. Food and Drug Administration.