New FDA Revlimid Approval Extends Celgene's Myeloma Empire
Executive Summary
Celgene is finally able to market its mainstay multiple myeloma therapy Revlimid for maintenance use after stem cell transplant, after the FDA further expanded its approved indications. The EU is set to follow suit following a CHMP positive opinion last month.
You may also be interested in...
Keeping Track: US FDA Files Another Pfizer Cancer Biologic And TMC's New Antibiotic
The latest drug development news and highlights from our FDA Performance Tracker.
New EU Nod For J&J/Genmab's Darzalex Brings It Closer To Rivals
The EU's CHMP has given the go ahead to extend the EU licence for Janssen/Genmab's Darzalex to include its use earlier in the treatment paradigm, bringing into line with the US label and its rivals.
CHMP’s January Recommendations Include Tofacitinib And Biosimilar Adalimumab
The European Medicines Agency’s Committee for Medicinal Products for Human Use notes also that Sandoz withdrew its application for the biosimilar Zioxtenzo (pegfilgrastim).