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CBER director Vinay Prasad overrules the Centers career reviewers in deciding to issue Moderna a refusal-to-file letter for its BL...[ Price : $8.95]
Politico says some GOP senators expressed frustration with FDA over a lack of apparent progress on its supposed safety review of t...[ Price : $8.95]
A detailed Reuters report looks at instances of surgical adverse events that may be related to artificial technology-enhanced medi...[ Price : $8.95]
FDA approves Novocures Optune Pax for use in combination with gemcitabine and nab-paclitaxel for adults with locally advanced panc...[ Price : $8.95]
FDA sends Sobi Inc. an untitled letter that cites a direct-to-consumer television advertisement for its myelofibrosis drug Vonjo (...[ Price : $8.95]
FDA warns Phoenix, AZ-based Signature Formulations about repeat CGMP violations in its manufacturing of finished drugs as a contra...[ Price : $8.95]
FDA cites Lonza Portsmouth for significant manufacturing and quality control deficiencies at its cell therapy facility where Verte...[ Price : $8.95]
A Washington Post opinion article takes issue with FDAs recent decision to reject a low-dose atropine treatment for pediatric myop...