The FDA will review the drug for refractory indolent non-Hodgkin's lymphoma.
The agency extended the review time for Biogen's Alprolix by three months.
The FDA told the drugmaker in a letter before the December PDUFA date that evidence does not support an expanded indication.
GSK sees a regulatory setback on its once-weekly GLP-1 med, and Spectrum Pharma gets hit with an untitled letter from OPDP on a sales aid for Zevalin.
With sequester cuts taking effect and no sign of a deal to end them in sight, FDA stands to lose 5% of its 2013 budget—though coming five months into the Federal fiscal year, it will feel more like 9%—and while the agency has said it has no plans at present for layoffs, it's certain the approvals process will slow as the agency absorbs the loss.