Following the FDA giving the green light to seven new medicines in December, it brought the approval total of new molecular entities (NMEs) in 2020 to 53, an amount that equals the number of new medicines that were approved in 1996 and ranking it second equal all-time just behind the 59 NMEs that were approved in 2018.
Viiv Healthcare Ltd., late Thursday, won FDA approval for Rukobia (fostemsavir), a gp120-directed attachment inhibitor for the treatment of adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. The drug was reviewed under FDA's fast track and breakthrough therapy status programs.