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FDA says the Abiomed 6/23/2025 correction to user instructions for its Automated Impella Controllers was Class 1.[ Price : $8.95]
FDA warns Wilington, DE-based Agebox about selling misbranded unapproved new drugs.[ Price : $8.95]
FDA releases the form FDA-483 with three observations from an inspection at Chinas Lonza Guangzhou Pharmaceutical active pharmaceu...[ Price : $8.95]
The CDER Office of Prescription Drug Promotion says an Esperion TV spot for Nexlizet falsely claims it is the only FDA-approved dr...[ Price : $8.95]
A biopharmaceutical expert petitions FDA to establish a risk-based regulatory framework for peptide therapeutics.[ Price : $8.95]
At a 12/11/2025 MDUFA 6 reauthorization meeting, FDA presented its views on changes involving using real-world evidence and calcul...[ Price : $8.95]
FDA releases the form FDA-483 with nine observations from an inspection at Greeces Pharmathen International.[ Price : $8.95]
FDA issues a complete response letter to Outlook Therapeutics seeking additional confirmatory evidence for its BLA for Lytenava to...