TORONTO and CHICAGO, Sept. 19, 2022 (GLOBE NEWSWIRE) -- On Friday, September 16, Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) was informed by medac, licensor of Medexus’s commercialization rights to treosulfan, that the U.S. Food and Drug Administration (FDA) has delivered to medac a second notice of incomplete response regarding medac’s new drug application resubmission for treosulfan (NDA). The FDA’s notice requests further supporting information from medac to complete medac’s NDA resubmission but does not require submission of new clinical data. Medexus will provide an update to its shareholders and stakeholders once management knows whether the resubmission has been accepted and is better able to assess the impact of this delay.
(RTTNews) - Medexus Pharmaceuticals (MDP.TO, MEDXF.OB) and its strategic partner medac announced Monday that medac has resubmitted its New Drug Application (NDA) for treosulfan with the U.S. Food and Drug Administration (FDA).
Study's primary endpoint and key secondary endpoints were metStudy found event-free survival and overall survival superior after treosulfan compared to RIC Treosulfan, also found non-relapse mortality...
TORONTO, CHICAGO and MONTREAL, June 10, 2021 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP) (OTCQX: MEDXF) (Frankfurt: P731) today announced that it has expanded its medical affairs team in preparation for the planned launch of treosulfan, a bifunctional alkylating agent, in the United States.