FDA accepted the supplemental Biologics Application for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage 2A to 3B non-small cell lung cancer. FDA assigned a Prescription Drug User Fee Act goal date of Oct. 8.
More than a year after a catastrophic shortage of platinum-based chemotherapy drugs swept through the U.S., FDA on June 28 officially removed carboplatin and cisplatin from the drug shortage list.
