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 sends Sobi Inc. an untitled letter that cites a direct-to-consumer television advertisement for its myelofibrosis drug Vonjo (pacritinib) because ...
FDA warns Phoenix, AZ-based Signature Formulations about repeat CGMP violations in its manufacturing of finished drugs as a contract facility.
FDA cites Lonza Portsmouth for significant manufacturing and quality control deficiencies at its cell therapy facility where Vertex Pharmaceuticals an...
A Washington Post opinion article takes issue with FDAs recent decision to reject a low-dose atropine treatment for pediatric myopia despite a large c...
FDA moves to blunt criticism of the Commissioners National Priority Voucher Program with a news release containing 18 questions and answers, making th...
FDA warns Mark Dacey of Denver, CO, about failing to obtain informed consent for two clinical investigations he conducted.
