approval
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Disability Support & Independent Living
FDA Withdraws Approval of Wellcovorin, GSK’s Branded Leucovorin, Amidst Complex History of Autism Treatment Claims
United States regulators have formally withdrawn the Food and Drug Administration’s (FDA) approval for Wellcovorin, the branded version of leucovorin…
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Alzheimer’s & Dementia Care
Kisunla approval offers new option for early Alzheimer’s in Europe
The European Commission has granted marketing authorization for Eli Lilly’s monthly infusion therapy, Kisunla (donanemab), targeting adults with early symptomatic…
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Alzheimer’s & Dementia Care
FDA Grants Priority Review to Axsome Therapeutics’ AXS-05 for Alzheimer’s Agitation, Accelerating Potential Approval for a Critical Unmet Need
The U.S. Food and Drug Administration (FDA) has granted priority review to Axsome Therapeutics’ supplemental New Drug Application (sNDA) for…
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Alzheimer’s & Dementia Care
FDA Reviews Expanded Approval for Leqembi Iqlik: Subcutaneous Option for Early Alzheimer’s Treatment Initiation
The U.S. Food and Drug Administration (FDA) is currently reviewing a supplemental Biologics License Application (sBLA) seeking expanded approval for…
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