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Tag: Oral Alzheimer’s Drug
FDA Approves First Oral Alzheimer’s Drug: Legal, Ethical, and Policy Considerations in Drug Approval
On May 15, 2025, the U.S. Food and Drug Administration (FDA) approved the first-ever Oral Alzheimer's Drug, marking a significant milestone in both medical and regulatory history. The approval of this groundbreaking drug raises questions not only about the future of Alzheimer’s treatment but also about the legal and regulatory processes involved in the approval of new pharmaceuticals, especially in the context of highly politicized health issues. This article will explore the various aspects of this approval, focusing on the legal framework, potential policy ramifications, and public debates surrounding the drug’s approval. At the core of the discussion is the tension between rapid innovation in healthcare and the regulatory mechanisms that ensure drug safety and efficacy.