New FDA Revlimid Approval Extends Celgene's Myeloma Empire
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.
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The latest drug development news and highlights from our FDA Performance Tracker.
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.
The European Medicines Agency’s Committee for Medicinal Products for Human Use notes also that Sandoz withdrew its application for the biosimilar Zioxtenzo (pegfilgrastim).