Lecanemab decision marks first time patients can begin treatment with home administration ...
The FDA has approved a subcutaneous version of isatuximab (Sarclisa Escena, Sanofi-Aventis) for several multiple myeloma (MM) ...
The FDA has launched a free mobile app version of its Drugs@FDA online database that offers consumers information on agency-approved drugs. The new app, called Drugs@FDA Express, is free and currently ...
This roundup highlights a number of FDA actions in June related to therapeutics for psychiatric illness. For information on approvals in other specialties during the first quarter of 2026, see our FDA ...
The proposed rule would allow multiple manufacturing units at different locations to register as one establishment.
When the FDA learned that a testing facility in India had submitted fraudulent data for more than 400 drugs (most of them generics), the agency should have withdrawn them from the market. Instead, it ...
Federal law requires every prescription drug to include a document describing dosing guidelines, contraindications, results from clinical trials and safety considerations. But a spate of recent court ...
Uncertainties about the benefits and harms of new drugs are common at the time of drugs’ approval. It is unclear to what extent the Food and Drug Administration (FDA) communicates these uncertainties ...