2002, Food and Drug Administration and Side effects

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2002

Food and Drug Administration

Side effects

Treating Alzheimer’s: regulatory hurdles in an anti-amyloid revolution

European Pharmaceutical Review

AUGUST 3, 2023

The US Food and Drug Administration (FDA) recently converted the accelerated approval of the drug, granted in January 2023 , to a full authorisation on the back of data from pivotal clinical studies conducted by the marketing authorisation holder, Eisai 1. References Drugs@FDA: FDA-Approved Drugs.

Food and Drug Administration

Food and Drug Administration Medicine FDA Marketing

Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

Food and Drug Administration

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Treating Alzheimer’s: regulatory hurdles in an anti-amyloid revolution

Paving the way for anti-Abeta active immunotherapy

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