FDA denies all five Ipsen Pharmaceuticals requests for agency actions on ANDAs for a generic form of Ipsens Somatuline Depot.
The FY 2023 GDUFA Science and Research Report examines GDUFA-funded research in eight priority areas affecting generic drug development and oversight.
CDER, CBER, and CDRH directors tell Congress they need additional legal authorities to be able to continue to provide the services patients and provid...
FDA grants Theriva Biologics a fast-track designation for its lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel for tr...
Pharmaceutical Research and Manufacturers of America asks FDA to address four issues relating to implementation of the FDA Reauthorization Act.
Federal Register notice: FDA extends the comment period on its proposed rule entitled Labeling Requirements for Approved or Conditionally Approved New...
Based on disappointing Phase 3 trial data, Otsuka Pharmaceutical terminates its development of the novel compound AVP-786 as a potential treatment for...
FDA asks an advisory panel to vote on the safety and effectiveness of the Guardant Shield colorectal screening test for use with patients at average r...
