The FDA has issued a complete response letter to the biologics license application seeking the approval of the on-body injector presentation of pegfilgrastim-cbqv, which is a biosimilar of pegfilgrastim.
Efficacy of BIO 300 was compared to PEGfilgrastim (Neulasta®).MINNEAPOLIS (BUSINESS WIRE) A recently published paper in Radiation Research, the official journal of the Radiation Research Society, details the results from studies conducted with Humanetics Corporation’s (Humanetics) new radioprotective drug, BIO 300.