The FDA has granted Plus Therapeutics Inc. fast track designation for its lead candidate, Rhenium Nanoliposomes (RNL), for treating recurrent glioblastoma, propelling it into the sixth cohort of a phase I dose-finding trial.
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.
Carmell Therapeutics Corp., of Pittsburgh, received fast track designation from the U.S. FDA for its first product, CT-101, a bone healing accelerant. Carmell is gearing up for a phase III study of the plasma-based bioactive accelerant as part of its pursuit of a biologic license application.