Device indicated for newly diagnosed glioblastoma.
MimiVax, Inc., a biotechnology company focused on the development of glioblastoma vaccine therapy, announced in a company press release that the FDA has granted fast track designation (FTD) to MimiVax's SurVaxM vaccine being studied for the treatment of newly diagnosed glioblastoma (nGBM). MimiVax is focused on completing the Phase 2b survive study and securing funding necessary to bring SurVaxM through the FDA approval process.
"The receipt of Fast Track Designation affirms the importance of new clinical developments of novel therapies to improve the treatment and outcomes for patients with newly diagnosed glioblastoma," said Michael Ciesielski, CEO, MimiVax. "This designation is a key component in our journey to help patients with glioblastoma to live longer."
Reference: MimiVax Granted Fast Track Designation from FDA for SurVaxM for Newly Diagnosed Glioblastoma. PR Newswire. October 12, 2023. Accessed October 13, 2023. https://www.prnewswire.com/news-releases/mimivax-granted-fast-track-designation-from-fda-for-survaxm-for-newly-diagnosed-glioblastoma-301954795.html
PD-L1 IHC 22C3 pharmD approved to help identify patients who may be eligible to receive treatment with pembrolizumab (Keytruda) to treat gastric or gastroesophageal junction adenocarcinoma.