FDA Approves Amivantamab-Chemo Combo for Advanced NSCLC
September 19th 2024The FDA approved amivantamab-vmjw plus chemotherapy for locally advanced or metastatic non–small cell lung cancer (NSCLC) that harbors EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR TKI.
BLA Resubmission Accepted by the FDA for Remestemcel-L in Pediatric Steroid-Refractory aGVHD
August 11th 2024The biologics license application that was resubmitted for remestemcel-L has been accepted by the FDA for the potential treatment of children with steroid-refractory acute graft-vs-host-disease.