JANSSEN RESEARCH & DEVELOPMENT LLC said a supplemental New Drug Application for ibrutinib (Imbruvica) has been submitted to FDA for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy. The filing is based on data from the multi-center, open-label Phase II PCYC-1121 trial ((NCT01980628) assessing the use of ibrutinib, a BTK...
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.
