FDA approves a GlaxoSmithKline BLA for its Shingrix (zoster vaccine recombinant, adjuvanted) for preventing shingles (herpes zoster) in adults aged 50...
Octapharma USA withdraws two lots of Octagam 10% [immune globulin intravenous (human)] liquid preparation] that is labeled with lot numbers K724B8541 ...
FDA Review posts the Federal Register notices for the week ending 10/20/2017.
FDA posts 51 product-specific guidances (32 new and 19 revised) describing the agencys current thinking and expectations on how to develop certain gen...
FDA says it is paying equal attention to medical device manufacturers struggling alongside drug makers in Puerto Rico as they work to return productio...
Federal Register notice: FDA announces an extension of the deadline to provide Logical Observation Identifiers Names and Codes for clinical laboratory...
Federal Register notice: FDA classifies devices that detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class 2 (special...
Celgene discontinues its Phase 3 REVOLVE trial (CD-002) in Crohns disease and the extension trial (SUSTAIN, CD-004) that are both studying GED-0301 (m...