CDER posts a drug development qualifying tool to support treatments for alcohol use disorder products.
FDA places a clinical hold on a Phase 3 study evaluating Modernas trivalent vaccine against norovirus (mRNA-1403) after a case of Guillain-Barr syndro...
FDA approves Sanofi-Aventis Merilog (insulin-aspart-szjj) as a biosimilar to Novo Nordisks Novolog (insulin aspart) for improving glycemic control in ...
Abiomed recalls its Impella RP with SmartAssist and Impella RP Flex with SmartAssist heart pumps to update their use instructions due to a risk that t...
The Trump administration adds a gender ideology statement to two Web pages on draft guidances that FDA was ordered by a federal judge to restore earli...
Bristol Myers Squibb says a Phase 3 trial evaluating Opdualag (nivolumab and relatlimab-rmbw) for treating patients with completely resected stage III...
The Kaiser Permanente healthcare system calls for FDA and congressional changes to improve the utility of the drug accelerated approval pathway.
FDA approves an Astellas Pharma supplemental NDA for Izervay (avacincaptad pegol intravitreal solution) that revises the labeling for the drugs use in...
