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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 ...
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 ...
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FDA commissioner says new vaccine ‘framework’ for industry is coming within weeks
A top agency official is meeting with industry and FDA staff as he works on guidance clarifying the FDA’s expectations for ...
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.” ...
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 ...
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FDA approves gene-editing technology for swine
The FDA recently approved a gene-editing technology used to make swine resistant to porcine reproductive and respiratory ...
FDA Upheaval Pushes Some Biotech Firms to Plan Early Trials Out of US
The FDA did not respond to a request for comment. U.S. Health Secretary Robert F. Kennedy Jr. has said that the agency's ...