News
The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license ...
The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (CT03767348) trial in advanced melanoma was not ...
Replimune said the agency had issued a complete response letter regarding the company’s biologics license application for RP1 ...
Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted ...
The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.
Vusolimogene oderparepvec is a genetically modified herpes simplex type 1 virus designed to directly destroy tumors and generate an anti-tumor immune response.
Replimune stock fell after the FDA rejected its RP1 application, citing flaws in the trial design and lack of substantial evidence for approval.
Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration ...
7h
TipRanks on MSNReplimune receives complete response letter from FDA for RP1 BLAReplimune (REPL) announced that the U.S. Food and Drug Administration, FDA, has issued a Complete Response Letter, CRL, regarding the Biologics ...
Perioperative treatment with nivolumab and relatlimab provided long-term benefits in adults with stage III-IV, resectable melanoma.
Scancell Holdings plc (AIM: SCLP), the developer of Immunobody ® and Moditope ® active immunotherapies to treat cancer, announces further positive data from the ongoing Phase 2 SCOPE trial of ...
Impact of antitumor activity on survival outcomes, and nonconventional benefit, with nivolumab (NIVO) in patients with advanced hepatocellular carcinoma (aHCC): Subanalyses of CheckMate-040. Authors : ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results