Pfizer: FDA panel recommends approval of Mylotarg.
(CercleFinance.com) - On Wednesday Pfizer announced that a US Food and Drug Administration's advisory committee had recommended approval of its drug Mylotarg for acute myeloid leukemia.
The FDA's oncologic drug advisory committee decided that the drug demonstrated a favorable risk/benefit profile when added to chemotherapy for newly-diagnosed patients.
Pfizer said the FDA's decision on whether or not to approve Mylotarg is now expected by September 2017.
The role of the advisory committee is just to provide recommendations to the FDA.
Copyright (c) 2017 CercleFinance.com. All rights reserved.
The FDA's oncologic drug advisory committee decided that the drug demonstrated a favorable risk/benefit profile when added to chemotherapy for newly-diagnosed patients.
Pfizer said the FDA's decision on whether or not to approve Mylotarg is now expected by September 2017.
The role of the advisory committee is just to provide recommendations to the FDA.
Copyright (c) 2017 CercleFinance.com. All rights reserved.