FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee votes to recommend approval of Replimune's experimental oncolytic immunotherapy RP1 (vusolimogene oderparepvec) in combination with Bristol Myers Squibb's Opdivo for patients with advanced melanoma.
A Friends of Cancer Research survey report documents bottlenecks in U.S. oncology clinical trial site scale-up activation and suggests ways to address the issues.
FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee votes to recommend approval of Replimune's experimental oncolytic immunotherapy RP1 (vusolimogene oderparepvec) in combination with Bristol Myers Squibb's Opdivo for patients with advanced melanoma.
A Friends of Cancer Research survey report documents bottlenecks in U.S. oncology clinical trial site scale-up activation and suggests ways to address the issues.
Sen. Ron Johnson asks to interview four former CBER officials and Anthony Fauci on the safety and efficacy of Covid vaccines.
A BioProcess International column praises a new FDA final guidance for introducing some flexibilities into approval of cell and gene therapy products while maintaining regulatory rigor.
