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News Breaks
June 9, 2014
08:18 EDTPCYCPharmacyclics reports sNDA for Imbruvica accepted, priority review granted
Pharmacyclics announced that the FDA has accepted for filing its suplemental new drug application to support the review of Imbruvica in the treatment of patients with CLL and SLL who have received at least one prior therapy for a full approval. The target PDUFA date by which the FDA is planning to finalize the review of this application is October 7.
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November 12, 2014
07:53 EDTPCYCLeerink to hold a tour
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