Bayer Provides Update on Aliqopa® (copanlisib)
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WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced that, following discussions with the U.S. Food and Drug Administration (FDA), it will work with the FDA on a voluntary withdrawal of the Aliqopa® (copanlisib) U.S. New Drug Application for adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. Aliqopa® was granted accelerated approval by the FDA in September 2017 based on CHRONOS-1, an open-label, single-arm Phase II study. The FDA req
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