Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
Precigen to Begin Phase II Study of PRGN-2009, Keytruda in HPV-Positive Cervical Cancer
The FDA granted the firm permission to study the off-the-shelf T-cell vaccine with the immune checkpoint inhibitor in pretreated metastatic HPV-positive cervical cancer patients.
FDA Reviewing Iovance's BLA for Melanoma TIL Therapy; Decision Expected in November
Iovance said the FDA is reviewing its BLA, and if successful, lifileucel could be the first autologous cell therapy approved for solid cancer.
FDA Accepts BMS's NDA for Repotrectinib in ROS1-Positive NSCLC
The agency is reviewing data from the Phase II TRIDENT trial and expects to decide whether to approve the drug by Nov. 27.
FDA Approves Blue Earth Diagnostics' PSMA-Targeted Radiohybrid PET Imaging Agent
The agency approved Posluma for detecting PSMA-positive lesions in prostate cancer patients whose tumors are suspected to have metastasized or recurred.
Cepheid Nabs CE-IVD Mark for Molecular NPM1 Mutation Test for AML Monitoring
The test quantifies mutant NPM1 mRNA transcripts in peripheral blood specimens from patients with acute myeloid leukemia.