FDA issues an emergency use authorization for AstraZenecas Evusheld monoclonal antibody Covid pre-exposure prevention for some adults and pediatric pa...
Teligent Pharma recalls two lots of lidocaine HCl topical solution USP 4%, 50ml in a screw cap glass bottles, due to internal testing determining the ...
Gilead Sciences recalls two lots of Veklury (remdesivir 100 mg for injection) after confirming a complaint about the presence of glass particulates.
Former FDAers Joshua Sharfstein and Peter Lurie praise a new agency draft guidance that signals a broadened approach to drug product regulation by con...
Federal Register notice: FDA is publishing an order on its final determination requiring premarket notification (510(k)) for the generic device type: ...
FDA adds omicron updates to its Web page on viral mutations and their impact on Covid tests.
FDA issues draft guidances with clinical recommendations and chemistry, manufacturing, and controls recommendations for sponsors developing some antis...
The Natural Products Association says it is suing to force FDA to stop regulating N-acetyl-L-cysteine.