Attorney James Beck says a California federal court dismissed two Nexus Pharmaceutical suits against drug compounders due to implied preemption.
FDA grants an additional orphan drug designation for Agios mitapavit for treating sickle cell disease.
The Justice Department says Indivior Solutions was sentenced to pay $289 million under a plea agreement for criminal charges involving unlawful Suboxo...
The Alliance for a Stronger FDA lists six programs likely to get additional funding from the FY 21 agency budget.
Federal Register notice: FDA contemplates the grant of an exclusive patent license to Advion, Inc. (Ithaca, NY) for a government-owned patent for Dire...
FDA posts a safety labeling change for Genentechs Ocrevus.
FDA places GMP-related conditions on its recent emergency use authorization for Eli Lillys investigational monoclonal antibody therapy bamlanivimab fo...
FDA contracts with the University of Maryland Smith School of Business to research the possibility of increasing drug manufacturing in the U.S.