FDA lifts a partial clinical hold on PTC Therapeutics PTC518 for treating Huntingtons disease based on the agencys review of Phase 2 trial data (PIVOT...
FDA approves a new ulcerative colitis indication for AbbVies Skyrizi.
Federal Register notice: FDA corrects a 3/29 notice on the approval withdrawals of 30 ANDAs from multiple applicants due to Target Healths notificatio...
FDA publishes a guidance explaining how CVM assesses human user safety in applicable animal drug applications.
FDA tells NDA and ANDA sponsors they must repeat clinical and bioanalytical studies conducted for their applications by Synapse Labs in Pune, India, d...
Six stakeholders express appreciation for and suggest improvements to an FDA draft guidance on using real-world evidence in non-interventional studies...
FDA approves changes to the REMS for Kites lymphoma treatments Yescarta and Tecartus.
FDA releases the form FDA-483 issued with four observations following an inspection at the Dr. Reddys active pharmaceutical ingredient manufacturing f...
