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.
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...
Travere Therapeutics says it will submit an sNDA to FDA for a new indication for its Filspari to treat focal segmental glomerulosclerosis.
