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A new analysis from Harvard Law School argues that the U.S. drug regulators reliance on industry-paid user fees has left the agenc...[ Price : $8.95]
FDA approves 46 novel new drugs and 18 new biologics in 2025, fewer than in the previous two years, likely due to the staffing tur...[ Price : $8.95]
GSK says its investigational hepatitis B drug bepriovirsen met the primary endpoint in two pivotal Phase 3 trials, with regulatory...[ Price : $8.95]
FDA says it cant approve a Vanda sNDA for Hetlioz to treat jet lag disorder in its current form.[ Price : $8.95]
Moonlake Immunotherapeutics says that, based on recommendations from a meeting with FDA, it will submit a BLA in the second half o...[ Price : $8.95]
FDA warns Melbourne, FL-based Absolutely Natural about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA commissioner Marty Makary promotes limited regulatory scrutiny of many wearable devices and software tools, a significant poli...