PFE - ViiV Healthcare's cabotegravir nabs accelerated review in U.S. for HIV prevention

The FDA grants Breakthrough Therapy Designation to ViiV Healthcare's long-acting, injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP).Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.ViiV Healthcare is the HIV-focused joint venture between GlaxoSmithKline (GSK), Pfizer (PFE) and Shionogi (SGIOY).

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ViiV Healthcare's cabotegravir nabs accelerated review in U.S. for HIV prevention