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Breakthrough Therapy is a designation given by the U.S. Food and Drug Administration (FDA) to expedite the development and review of drugs that treat serious or life-threatening conditions. This designation is intended to help bring new treatments to patients faster than traditional drug development and review processes. Breakthrough Therapy is part of the larger Drug Discovery process, which involves the identification, development, and commercialization of new drugs.
Drug Discovery is a complex and lengthy process that involves the identification of a potential drug target, the development of a drug candidate, and the clinical testing of the drug candidate. The process is often lengthy and expensive, and the success rate is low. Breakthrough Therapy is intended to help reduce the time and cost associated with Drug Discovery by providing additional resources and support to drug developers.
Companies in the Breakthrough Therapy market include AbbVie, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer, and Roche. Show Less Read more