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After delay, FDA approves Novavax’s Covid-19 vaccine, but only for older people and those at high risk
After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter ...
FDA approves Novavax COVID-19 shot but with unusual restrictions
Novavax originally showed its vaccine was safe and effective in a 30,000-person clinical trial. The FDA had been on track to ...
RFK Jr.’s FDA Severely Restricts COVID Vaccine Use
The vaccine will only be available to those at high risk from Covid—excluding those who may need it to protect a relative or ...
FDA approves Novavax COVID vaccine with new conditions
The U.S. Food and Drug Administration on Friday approved Novavax's COVID-19 vaccine, but placed additional conditions on ...
FDA’s Makary: Covid shot guidance coming soon
FDA Commissioner Marty Makary announced Thursday that the agency will soon provide clear guidelines to vaccine manufacturers ...
FDA to issue new vaccine approval guidance amid questions over coronavirus shots
FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...
FDA to revisit approval of "yoga mat" bread ingredient banned in Europe
The FDA is prioritizing the review of some previously approved food additives, including ADA, dubbed the "yoga mat" chemical.
Bayer US head says FDA chief reassured pharma executives of timely reviews
Bayer Pharmaceuticals' chief operating officer said the head of the top U.S. drug regulator recently reassured industry ...