FDA News Recap: Novel Drug Approvals in First Half of 2026
• The US Food and Drug Administration (FDA) approved 22 novel drugs during the first half of 2026, expanding treatment options across various medical specialties. • Key approvals include copper histidinate (formerly CUTX-101) for Menkes disease, supported by two open-label studies involving 129 patients treated with subcutaneous administration for up to 3 years. • The FDA also granted approval for a new treatment targeting mild to moderate Alzheimer's disease (AD) based on phase 3 clinical trial data from both adult and pediatric populations.
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