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FDA warns Santa Fe Springs, CA-based Creative Essences about CGMP violations in its production of misbranded unapproved drugs.[ Price : $8.95]
FDA input offers Lexeo Therapeutics a potential accelerated approval pathway for its investigational gene therapy LX2006.[ Price : $8.95]
After being forced to resign in April, former CBER director Peter Marks accepts a job at Lilly Research Laboratories overseeing mo...[ Price : $8.95]
FDA lifts a clinical hold on Neurizon Therapeutics on its lead experimental treatment for amyotrophic lateral sclerosis.[ Price : $8.95]
FDA accepts for priority review an Orca Bio BLA for Orca-T, an investigational allogeneic T-cell immunotherapy for patients with c...[ Price : $8.95]
FDA grants IceCure Medicals de novo marketing authorization for the ProSense cryoablation system for treating early-stage, low-ris...[ Price : $8.95]
FDA issues Dr. Reddy's Laboratories a five-item Form FDA-483 after inspecting the firms drug substance and drug product manufactur...[ Price : $8.95]
AstraZeneca and Daiichi Sankyo report new data showing that their antibody-drug conjugate Datroway (datopotamab deruxtecan) signif...