U.S. regulators halted a trial of Novartis’ Zolgensma treatment after an animal study raised safety concerns, in a setback for the drugmaker’s plan to expand the product’s use to older patients.
The U.S. Food and Drug Administration lifted a partial clinical hold placed on AbbVie’s Phase III CANOVA trial evaluating venetoclax for the treatment of relapsed/refractory multiple myeloma.
The U.S. Food and Drug Administration placed a partial clinical hold on all trials of AbbVie’s Venclexta for multiple myeloma, after a review of data found a higher proportion of deaths in the cancer drug arm of the late-stage study.
The U.S. Food and Drug Administration placed Princeton, N.J.-based Advaxis’ Phase III clinical trial of axalimogene filolisbac (AXAL) in advanced cervical cancer on partial clinical hold.
Two Roche drugs were placed on partial clinical hold as the U.S. FDA continues to examine potential dangers of checkpoint inhibitors following deaths associated with Merck’s Keytruda.