- 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 (NYSE:GSK), Pfizer (NYSE:PFE) and Shionogi (OTCPK:SGIOY).
- https://seekingalpha.com/news/3637361-viiv-healthcares-cabotegravir-nabs-accelerated-review-in-u-s-for-hiv-prevention
Wednesday, November 18, 2020
ViiV cabotegravir nabs accelerated review in U.S. for HIV prevention
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