EP. 6: FDA Grants Safe to Proceed Letter to IND of Ropidoxuridine in GBM
January 8th 2024A Safe to Proceed letter from the FDA has been granted to the investigational new drug application of a phase 2 study evaluating ropidoxuridine plus radiotherapy in patients with newly diagnosed IDH-wildtype glioblastoma.
EP. 7: FDA Issues Complete Response Letter to Zolbetuximab BLA in GI Cancer
January 9th 2024The FDA has issued a complete response letter to the biologics license application of zolbetuximab for patients with advanced, HER2-negative, claudin 18.2-positive gastric or gastoesophageal junction adenocarcinoma.
EP. 17: FDA Expands HT-001 Trial to Include Cancers With EGFR-Associated Toxicities
January 18th 2024Following clearance from the FDA, Hoth Therapeutics is carrying out a clinical trial as part of its open investigational new drug program for HT-001 in cancers undergoing toxicities from EGFR inhibition.