The HHS Office of Inspector General discloses it has opened an investigation into Alexion Pharmaceuticals business practices.
Federal Register notice: FDA announces a 7/26 joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and R...
FDA agrees to a consent decree of permanent injunction against Medistat RX LLC (Foley, AL) and certain company officials due to making non-sterile dru...
The House Energy and Commerce Subcommittee on Health announces a 7/12 hearing on Examining Medical Product Manufacturer Communications, including FDA ...
FDA says that it has not received any additional adverse events associated with severe bleeding and hematomas with Baxter Internationals Vascu-Guard p...
FDA approves an Emmaus Medical NDA for Endari (L-glutamine oral powder) for patients five years and older with sickle cell disease to reduce severe c...
Federal Register notice: FDA announces an 8/3 Arthritis Advisory Committee meeting that will review a Pfizer supplemental NDA for Xeljanz (tofacitinib...
Senator Orrin Hatch (R-UT) introduces the Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2017.