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...
A Buchannan Ingersoll petition asks FDA to impose conditions on ANDAs for generic forms of the cancer drug Leukeran.
Endo asks FDA not to receive or approve any applications for a generic form of Endos epinephrine products that do not refer to the Endo NDA.
The U.S. Senate votes 52-48 to confirm vaccine skeptic Robert F. Kennedy Jr. to serve as the next HHS secretary.
Researchers in China say they found several new adverse event signals in their review of 20 years of FDA adverse event reports on the antidepressant 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 ...
