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.
FDA releases its latest batch of Warning Letters that includes one medical product company Shandong Analysis and Test Center.
FDA releases a draft work plan outlining how it will allocate $500 million over the next nine years to implement the 21st Century Cures Act.
CDER officials advocate for more use of master protocols for precision medicine trials to evaluate targeted therapies.