FDA says the Abiomed 6/23/2025 correction to user instructions for its Automated Impella Controllers was Class 1.
FDA warns Wilington, DE-based Agebox about selling misbranded unapproved new drugs.
FDA warns Melbourne, FL-based Absolutely Natural about CGMP violations in its production of finished drugs.
FDA releases the form FDA-483 with three observations from an inspection at Chinas Lonza Guangzhou Pharmaceutical active pharmaceutical ingredient man...
The CDER Office of Prescription Drug Promotion says an Esperion TV spot for Nexlizet falsely claims it is the only FDA-approved drug to lower LDL chol...
A biopharmaceutical expert petitions FDA to establish a risk-based regulatory framework for peptide therapeutics.
At a 12/11/2025 MDUFA 6 reauthorization meeting, FDA presented its views on changes involving using real-world evidence and calculating the 510(k) tim...
