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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 awards Krystal Biotech a Regenerative Medicine Advanced Therapy designation for KB707, an inhalable gene therapy being investi...[ Price : $8.95]
FDA approves Mercks Keytruda (pembrolizumab), as well as the fixed-dose combination pembrolizumab and berahyaluronidase alfa-pmph ...[ Price : $8.95]
FDA cites AGC Biologics for deficiencies in laboratory data controls and inventory management at its Bothell, WA, drug substance m...[ Price : $8.95]
FDA accepts for review a Biofrontera supplemental NDA seeking to expand the label of its photodynamic therapy drug Ameluz (aminole...