Federal Register notice: FDA announces a 3/19 workshop on Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Settings.
FDA principal deputy commissioner Rachel Sherman says the agency has to do a better job of preparing the next generation of staff leaders to take over...
FDA approves a Janssen NDA for Erleada (apalutamide) for treating patients with prostate cancer that has not spread, but that continues to grow despit...
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Warner-Lamberts Ibrance (palbociclib) is 3...
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Boehringer Ingelheims Jardiance (empaglifl...
Merck ends a Phase 3 study of verubescesat in Alzheimers disease patients.
The National Institute of Allergy and Infectious Diseases says it is studying whether blood levels of procalcitonin can predict whether a lower respir...
FDA warns Bayer Pharma about CGMP inspection violations at its drug manufacturing facility in Leverkusen, Germany.