Breaking news
Coave Therapeutics Preparing for Retinitis Pigmentosa Gene Therapy Registration Trial
In an ongoing Phase I/II trial, the gene therapy improved visual function in patients with early stages of the rare, inherited visual disorder.
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.
RayzeBio Advances RYZ101 to Phase III Study in SSTR-Positive Neuroendocrine Tumors
The firm will compare its investigational radiopharmaceutical to standard therapies in patients with SSTR-positive gastroenteropancreatic neuroendocrine tumors.
Yuhan Licenses HER2 Inhibitor From J INTS Bio in $325M Deal
J INTS Bio is evaluating JIN-A04 in preclinical studies as a treatment for HER2 exon 20-mutant non-small cell lung cancer.
Anew Medical Expecting to Access $54M Following SPAC Merger
The company is hoping the capital will help it advance a pipeline of gene therapies for various neurodegenerative diseases.
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.
In Brief This Week: Clarity Pharmaceuticals, Regenxbio, Rocket Pharmaceuticals, Eisai, AstraZeneca
News items for the week of May 22, 2023.