Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
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 November 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.
In Brief This Week: Clarity Pharmaceuticals, Regenxbio, Rocket Pharmaceuticals, Eisai, AstraZeneca
News items for the week of May 22, 2023.
Bristol Myers Squibb Eyeing CLL, SLL as Additional Breyanzi Indications After Positive Readout
Around 18 percent of patients in a Phase I/II trial with aggressive, treatment-refractory forms of leukemia had complete responses on the CAR T-cell therapy.
May 11, 2023