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Home > New FDA Approvals > 119 - FDA refuses Alkermes' depression treatment; EU expanded indication for denosumab; FDA approval for Impella CP®; FDA’s efforts to enhance the patient perspective.
Podcast: New FDA Approvals
Episode:

119 - FDA refuses Alkermes' depression treatment; EU expanded indication for denosumab; FDA approval for Impella CP®; FDA’s efforts to enhance the patient perspective.
Category: Science & Medicine
Duration: 00:09:42
Publish Date: 2018-04-03 07:00:00
Description:

April 3, 2018 

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1:12 FDA refuses to review Alkermes' depression treatment, seeks more trials https://www.reuters.com/article/us-alkermes-fda/fda-refuses-to-review-alkermes-depression-treatment-seeks-more-trials-idUSKCN1H90W5

2:40 Amgen: European Commission approves expanded indication for XGEVA http://www.iii.co.uk/alliance-news/1522734525290370500-3/amgen-european-commission-approves-expanded-indication-for-xgeva 

3:46 Abiomed receives FDA approval for Impella CP® with SmartAssist™ and optical sensor https://www.nasdaq.com/press-release/abiomed-receives-fda-approval-for-impella-cp-with-smartassist-and-optical-sensor-20180402-00312 

4:49 Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to enhance the patient perspective and experience in drug development and review https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm602999.htm 

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