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New FDA Drug Approvals for 2026 - Drugs. com Up to date information on the latest FDA drug approvals Includes list of most recent approvals, the conditions approved for, and the approval history
FDA Approves Treatment for Serious Liver Disease Known as . . . The U S Food and Drug Administration has approved Wegovy (semaglutide) injection to treat metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced fibrosis (excessive scar
FDA approves Denali Hunter syndrome drug - fiercepharma. com The FDA has approved Denali Therapeutics’ enzyme replacement therapy for a genetic lysosomal storage disease after a string of high-profile rejections for rare disease candidates In approving
FDA approves 1st non-antipsychotic medication for agitation . . . The Food and Drug Administration (FDA) approved the drug Auvelity this week for the treatment of agitation in adults with Alzheimer's dementia The extended-release tablet is the first FDA-approved medication for this condition that is not an anti-psychotic Anti-psychotics carry serious risks including stroke, sedation and increased death in older adults, according to the FDA Having a non
Search Orphan Drug Designations and Approvals This page searches the Orphan Drug Product designation database Searches may be run by entering the product name, orphan designation, and dates Results can be displayed as a condensed list, detailed list, or an Excel spreadsheet Click for detailed instructions
FDA Approves Auvelity for Treatment of Agitation in Alzheimer . . . The US Food and Drug Administration has approved Axsome Therapeutics’ oral dextromethorphan-bupropion (Auvelity, formerly known as AXS-05) for the treatment of agitation associated with Alzheimer disease (AD) 1 Auvelity is a first-in-class treatment for AD agitation which targets the N-methyl D-aspartate (NMDA) and sigma-1 receptors “The approval of our first-in-class medication for
FDA Approves Auvelity for Alzheimer Disease-Related Agitation Auvelity was initially approved in 2022 to treat major depressive disorder in adults and is the first nonantipsychotic approved for agitation associated with dementia due to Alzheimer's disease The approval was based on a five-week trial in which participants received either Auvelity or a placebo