[ Price : $8.95]
FDA approves a new ulcerative colitis indication for AbbVies Skyrizi.[ Price : $8.95]
Federal Register notice: FDA corrects a 3/29 notice on the approval withdrawals of 30 ANDAs from multiple applicants due to Target...[ Price : $8.95]
FDA publishes a guidance explaining how CVM assesses human user safety in applicable animal drug applications.[ Price : $8.95]
FDA tells NDA and ANDA sponsors they must repeat clinical and bioanalytical studies conducted for their applications by Synapse La...[ Price : $8.95]
Six stakeholders express appreciation for and suggest improvements to an FDA draft guidance on using real-world evidence in non-in...[ Price : $8.95]
FDA approves changes to the REMS for Kites lymphoma treatments Yescarta and Tecartus.[ Price : $8.95]
FDA releases the form FDA-483 issued with four observations following an inspection at the Dr. Reddys active pharmaceutical ingred...[ Price : $8.95]
FDA publishes a guidance describing the behaviors the agency sees as delaying, denying, limiting, or refusing a drug or device ins...