Jazz Pharmaceuticals plc has reported that the Biologics License Application for zanidatamab, has been accepted and given Priority Review status by the U.S. Food and Drug Administration.
Astellas Pharma Inc. revealed that the U.S. Food and Drug Administration has recognized their resubmission of the Biologics License Application for zolbetuximab.
Johnson & Johnson has applied to the European Medicines Agency for approval of a subcutaneous version of RYBREVANT® (amivantamab) to treat patients with EGFR-mutated non-small cell lung cancer.
Bristol Myers Squibb has revealed that the U.S. Food and Drug Administration has given the green light to Breyanzi® (lisocabtagene maraleucel; liso-cel).
The European Commission has approved Bristol Myers Squibb's Opdivo® (nivolumab) combined with cisplatin and gemcitabine for first-line therapy in adults with unresectable or metastatic urothelial carcinoma.
Jazz Pharmaceuticals plc revealed that the U.S. Food and Drug Administration (FDA) has accepted and given Priority Review status to the Biologics License Application (BLA) for zanidatamab.
CDR-Life Inc. has started enrolling participants for the Phase 1 clinical trial of CDR404, their leading candidate being developed as a targeted immunotherapy for the treatment of solid tumors.