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llllllllll envafolimab (KN035) / 3DMed, Tracon, AscletisTRACON Pharmaceuticals Announces FDA Clearance of ENVASARC Pivotal Trial (GlobeNewswire) - Aug 17, 2020 - "TRACON Pharmaceuticals…to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., today announced the clearance of the pivotal ENVASARC protocol after filing the protocol with the U.S. Food and Drug Administration (FDA) as part of an Investigational New Drug (IND) application on July 15….TRACON expects to initiate enrollment in the ENVASARC trial at 25 sites in the U.S. in the fourth quarter of 2020."llllllllll trilaciclib (G1T28) / G1 TherapG1 Therapeutics Announces Acceptance and Priority Review of NDA for Trilaciclib for Patients with Small Cell Lung Cancer (GlobeNewswire) - Aug 17, 2020 - "G1 Therapeutics, Inc…announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for trilaciclib for small cell lung cancer (SCLC) patients being treated with chemotherapy and granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of February 15, 2021….The trilaciclib NDA was supported by compelling myelopreservation data from three randomized, double-blind, placebo-controlled clinical trials in which trilaciclib was administered prior to chemotherapy treatment in patients with SCLC."
