BESREMi® (Ropeginterferon alfa-2b) deemed safe and efficacious by the US FDA
BESREMi® (Ropeginterferon alfa-2b) deemed safe and efficacious by the US FDA BESREMi® (Ropeginterferon alfa-2b) deemed safe and efficacious by the US FDA Wien (pts026/15.03.2021/15:15) - The US Food & Drug Administration (FDA) issued a complete response letter for the drug BESREMi® with the active pharmaceutical ingredient Ropeginterferonalfa-2b, in which the FDA confirms the efficacy and safety of the drug. This assessment was based on the clinical development program by the European rare disease company AOP Orphan. On March 12, 2021, according to PharmaEssentia Corp., the FDA in the...
Source: pressetext.com