Public Citizen calls on the FTC to block the proposed merger of Pfizers Upjohn unit with Mylan.
Federal Register notice: FDA announces fiscal year 2020 rates for the establishment and re-inspection fees related to drug compounding outsourcing fac...
CDER says its NextGen Portal can receive pre-assigned NDA, IND, BLA, and DMF number requests starting 8/19.
Leaders of the House Energy and Commerce Committee ask FDA for a briefing on the potential for a shortage of heparin in the U.S. due to an African swi...
FDA accepts for review a Sunovion Pharmaceuticals NDA for dasotraline for treating patients with moderate-to-severe binge eating disorder.
Federal Register notice: FDA seeks comments on a new information collection entitled Obtaining Information To Understand Challenges and Opportunities ...
FDA posts a guidance entitled Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention.
FDA grants Orchard Therapeutics a Regenerative Medicine Advanced Therapy designation for the companys ex vivo autologous hematopoietic stem cell-based...