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BRIEF-Progenics Pharmaceuticals provides update on timing of NDA submission for Azedra
2017年8月31日 / 晚上8点15分 / 1 个月前

BRIEF-Progenics Pharmaceuticals provides update on timing of NDA submission for Azedra

Aug 31 (Reuters) - Progenics Pharmaceuticals Inc

* Progenics Pharmaceuticals provides update on timing of NDA submission for Azedra

* Progenics - co was notified that commercial drug product manufacturing facility for Azedra needs more time to prepare for pre-approval inspection by FDA

* Progenics Pharma - ‍data from pivotal phase 2b study of azedra will be presented at 5th International Symposium On Pheochromocytoma & Paraganglioma on Sept. 1

* Progenics - ‍under rolling submission, co has submitted all portions of NDA to FDA, except for notification of pre-approval inspection readiness​

* Progenics Pharmaceuticals Inc - ‍interactions with FDA on Azedra rolling submission continue to be “positive and productive”​

* Progenics Pharmaceuticals - ‍manufacturer has indicated it will need up to a few months to complete preparation for pre-approval inspection​ by FDA Source text for Eikon: Further company coverage:

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