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Johnson & Johnson asks FDA to approve a new indication for its Tremfya to treat some adults with Crohns disease.[ Price : $8.95]
FDA grants Onkos Surgical a de novo authorization for its novel antibacterial coating for use with implants.[ 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Six stakeholders express appreciation for and suggest improvements to an FDA draft guidance on using real-world evidence in non-in...[ Price : $8.95]
Federal Register notice: FDA issues a final rule revising its requirements for current good manufacturing practice, postmarketing ...