GSK says its investigational hepatitis B drug bepriovirsen met the primary endpoint in two pivotal Phase 3 trials, with regulatory submissions schedul...
FDA says it cant approve a Vanda sNDA for Hetlioz to treat jet lag disorder in its current form.
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 approves 46 novel new drugs and 18 new biologics in 2025, fewer than in the previous two years, likely due to the staffing turmoil the agency expe...
FDA warns Melbourne, FL-based Absolutely Natural about CGMP violations in its production of finished drugs.
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.
