California reaches pay-for-delay settlements with four drug companies bringing $70 million to the state.
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.
FDA clears 510(k)s for four previously cleared Zeus Scientific tests with new indications to aid in diagnosing Lyme disease.
Federal Register notice: FDA seeks comments on a new information collection entitled Obtaining Information To Understand Challenges and Opportunities ...