Moonlake Immunotherapeutics says that, based on recommendations from a meeting with FDA, it will submit a BLA in the second half of 2026 for sonelokim...
FDA commissioner Marty Makary promotes limited regulatory scrutiny of many wearable devices and software tools, a significant policy shift aimed at mo...
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...
