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FDA posts a draft guidance entitled Certification Process for Designated Medical Gases.
The CDER Office of Prescription Drug Promotion cautions Janssen Biotech about a direct-to-consumer TV ad for Tremfya that misleadingly overstates the ...
CBER director Vinay Prasad overrules the Centers career reviewers in deciding to issue Moderna a refusal-to-file letter for its BLA for an influenza v...
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.
