FDA releases the FDA-483 issued following a 2016 inspection at Japans Sekisui Medical API manufacturer.
Amgen files a BLA for erenumab, a human monoclonal antibody for preventing migraine.
Attorney Stephen Wood says courts should require a stay of discovery in whistleblower cases until they have determined whether a case should be dismis...
The Supreme Court declines to hear an appeal of a 3rd Circuit Appeals Court ruling that a law firm lacks standing to challenge FDAs regulation of Jans...
The Trump administration reportedly wants to save money in next years NIH budget by capping payments for research grant indirect costs at 10%.
Pharmaceutical Manufacturing Research Services asks FDA to stay its approval of an Inspirion NDA for Roxybond.
Attorney James Beck says a New York federal court dismissed a suit against Bristol-Myers Squibb for not adding bleeding risk warnings to its Eliquis l...
FDA Oncology Center of Excellence director Richard Pazdur outlines the Centers accomplishments since its 1/2017 founding.