[ Price : $8.95]
FDA cites Laurus Labs (Hyderabad, India) over GMP deficiencies following a 12/2023 inspection at the firms active pharmaceutical i...[ Price : $8.95]
FDA denies all five Ipsen Pharmaceuticals requests for agency actions on ANDAs for a generic form of Ipsens Somatuline Depot.[ Price : $8.95]
The FY 2023 GDUFA Science and Research Report examines GDUFA-funded research in eight priority areas affecting generic drug develo...[ Price : $8.95]
CDER, CBER, and CDRH directors tell Congress they need additional legal authorities to be able to continue to provide the services...[ Price : $8.95]
FDA grants Theriva Biologics a fast-track designation for its lead clinical candidate VCN-01 in combination with gemcitabine and n...[ Price : $8.95]
Pharmaceutical Research and Manufacturers of America asks FDA to address four issues relating to implementation of the FDA Reautho...[ Price : $8.95]
Federal Register notice: FDA extends the comment period on its proposed rule entitled Labeling Requirements for Approved or Condit...[ Price : $8.95]
Based on disappointing Phase 3 trial data, Otsuka Pharmaceutical terminates its development of the novel compound AVP-786 as a pot...