BioCentury
ARTICLE | Clinical News

FDA grants Priority Review to Rituxan for pemphigus vulgaris

February 16, 2018 8:48 PM UTC

The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said FDA accepted and granted Priority Review to an sBLA for Rituxan rituximab to treat pemphigus vulgaris. Its PDUFA date is in 2Q18.

The chimeric mAb against CD20 antigen has breakthrough therapy and Orphan Drug designations from FDA for the indication (see BioCentury, April 19, 2017)...

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