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...
A Friends of Cancer Research study update says FDA continues to review and approve novel cancer drugs faster than the European Medicines Agency.
Sanofi and Johnson & Johnson stop the development of their vaccine candidate for extraintestinal pathogenic E. coli because Phase 3 data show that it ...
The DC District Court rules for FDA in a Vanda Pharmaceuticals lawsuit seeking an agency order to revoke the approval of a Teva ANDA for a generic cop...
The Kaiser Permanente healthcare system calls for FDA and congressional changes to improve the utility of the drug accelerated approval pathway.
