News

FDA funding clash looms between Senate, House
Despite the Trump administration’s efforts to shrink the FDA, Senate appropriators unanimously advanced a funding bill ...
STAT3h
FDA grants full approval to Moderna’s Covid vaccine for children but limits eligibility
Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S.
Infectious Disease Advisor4h
FDA Publishes Full Texts of Response Letters to Drug Applications
The US FDA has published more than 200 complete response letters sent as replies to drug and biological product applications.
KFF Health News5h
FDA Posts 200 Letters Citing Initial Concerns About Approved Drugs
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 ...
FDA to consider drug affordability when granting new vouchers to speed up approvals, Makary says
It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...
FDA mulls faster drug reviews in exchange for lower prices in U.S.- Bloomberg
FDA Commissioner Marty Makary suggests his agency may expedite drug reviews for manufacturers reducing U.S. prices to global ...
FDA Offers to Trade Faster Drug Reviews for Lower US Prices
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 ...