Progenics Pharmaceuticals Provides Update on Timing of NDA Submission for AZEDRA®
PROGENICS PHARMACEUTICALS (PGNX)
Last progenics pharmaceuticals earnings: 8/9 07:30 am
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Source: GlobeNewswire
- All Sections of New Drug Application (NDA) Have Been Submitted to the FDA, Except Notification of Pre-Approval Inspection Readiness - -Manufacturer Has Requested Additional Time to Prepare for Pre-Approval Inspection of the Manufacturing Site - NEW YORK, NY, Aug. 31, 2017 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and other products for targeting and treating cancer, today announced that it has been notified by its third-party vendor that the commercial drug product manufacturing facility for AZEDRA® requires more time to prepare for pre-approval inspection by the U.S. Food and Drug Administration (FDA). As a result, after consultation with the FDA, Progenics has decided to postpone the finalization of the New Drug Application (NDA) until the manufacturing site is inspection-ready. The manufacturer has indicated it will need up to a few months to complete this work. Under a rolling submission, Progenic
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