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Genentech Xolair

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The asthma agent may get reviewed at the tentatively scheduled April 26-27 Pulmonary-Allergy Drugs Advisory Committee meeting. Genentech is planning to submit additional platelet monitoring data in time for the meeting. "It is our absolute intention to get all of the data into the FDA to assure that we have a successful advisory committee if we are invited to participate" in the meeting, Genentech Chief Medical Officer Susan Desmond-Hellmann, MD, said during a conference call Jan. 18. The firm believes it is on track for a summer approva

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