Eugia U.S. recalls one lot of methocarbamol injection due to a customer product complaint about the presence of white particles floating inside a vial...
FDA approves a Gilead Sciences supplemental NDA for Vemlidy (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for chronic hepatitis B vi...
FDA clears a Synaptive Medical 510(k) for its near-infrared fluorescence visualization module, Modus IR, adding to the existing fluorescence offering ...
FDA approves a Medexus Pharmaceuticals supplemental BLA for Ixinity [coagulation factor IX (recombinant)] for treating pediatric patients under 12 yea...
Federal Register notice: FDA withdraws approval of 30 abbreviated new drug applications from multiple applicants because the drug products are no long...
Federal Register notice: FDA announces the over-the-counter Monograph Drug User Fee Program facility fee rates for fiscal year 2024.
Two attorneys who represented the Canton, MA-based Judge Rotenberg Center in its court case against FDAs efforts to ban the use of an electroshock or ...
