ARTICLE | Company News
Another setback for Spectrum's remaining pipeline after Rolontis BLA withdrawal
March 15, 2019 7:01 PM UTC
Spectrum said Friday that it withdrew a BLA for Rolontis eflapegrastim to treat chemotherapy-induced neutropenia.
Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) said it needs more time to provide additional manufacturing-related information to FDA, which was due before March 29. The company plans to resubmit a revised BLA for the long-acting G-CSF analog as soon as possible...