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Despite the Trump administration’s efforts to shrink the FDA, Senate appropriators unanimously advanced a funding bill ...
Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S.
The US FDA has published more than 200 complete response letters sent as replies to drug and biological product applications.
The FDA published a database of letters sent to drugmakers during the review process of medications that provide information on the agency's initial feedback or requirements for more data. These ...
It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...
FDA Commissioner Marty Makary suggests his agency may expedite drug reviews for manufacturers reducing U.S. prices to global ...
Food and Drug Administration Commissioner Marty Makary said his agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the US and other ...
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