Politico says some GOP senators expressed frustration with FDA over a lack of apparent progress on its supposed safety review of the abortion drug mif...
A detailed Reuters report looks at instances of surgical adverse events that may be related to artificial technology-enhanced medical devices being us...
FDA approves Novocures Optune Pax for use in combination with gemcitabine and nab-paclitaxel for adults with locally advanced pancreatic cancer.
FDA awards Krystal Biotech a Regenerative Medicine Advanced Therapy designation for KB707, an inhalable gene therapy being investigated for treating l...
FDA approves Mercks Keytruda (pembrolizumab), as well as the fixed-dose combination pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex), in ...
FDA cites AGC Biologics for deficiencies in laboratory data controls and inventory management at its Bothell, WA, drug substance manufacturing site.
FDA accepts for review a Biofrontera supplemental NDA seeking to expand the label of its photodynamic therapy drug Ameluz (aminolevulinic acid hydroch...
FDA posts a draft guidance entitled Certification Process for Designated Medical Gases.
