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 November 27.
FDA Sends Byondis Complete Response Letter Delaying Decision on HER2-Positive Breast Cancer Drug
Byondis submitted data on SYD985's activity from the Phase III TULIP trial, but the agency has requested additional information.
Guardant Health Pushing Hard to Contextualize CRC Screening Data as Core Business Chugs Along
The company is seeing continuing growth for its existing clinical products as it moves resources toward commercialization of its Guardant Shield CRC screening test.
FDA Accepts Pfizer sNDAs for Braftovi, Mektovi in BRAF V600E-Mutant NSCLC
The sNDA submissions include data from the Phase II PHAROS trial, results from which researchers will present at an upcoming medical meeting.