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Home > New FDA Approvals > 075 – CRP assay approval; gammaCore for migraine; revefenacin (TD-4208) for COPD; FIRVANQ™ For CDAD; intracranial hemorrhage software; CardiAMP cell therapy for chronic myocardial ischemia
Podcast: New FDA Approvals
Episode:

075 – CRP assay approval; gammaCore for migraine; revefenacin (TD-4208) for COPD; FIRVANQ™ For CDAD; intracranial hemorrhage software; CardiAMP cell therapy for chronic myocardial ischemia
Category: Science & Medicine
Duration: 00:14:06
Publish Date: 2018-01-30 07:00:00
Description:

January 30, 2018 

Please tell your colleagues about this podcast “just go to newfdaapprovals.com” 

1:30 Meso Scale Diagnostics receives first FDA Clearance for CRP assay https://www.prnewswire.com/news-releases/meso-scale-diagnostics-receives-first-fda-clearance-for-ivd-assay-300589350.html

2:34 GammaCore® receives FDA clearance for the acute treatment of pain associated with migraine headache in adult patients https://www.prnewswire.com/news-releases/gammacore-receives-fda-clearance-for-the-acute-treatment-of-pain-associated-with-migraine-headache-in-adult-patients-300589314.html 

4:16 Theravance Biopharma and Mylan Announce fda acceptance of new drug application for Revefenacin (TD-4208) in adults with chronic obstructive pulmonary disease https://www.prnewswire.com/news-releases/theravance-biopharma-and-mylan-announce-fda-acceptance-of-new-drug-application-for-revefenacin-td-4208-in-adults-with-chronic-obstructive-pulmonary-disease-300589307.html 

6:42 CutisPharma announces FDA Approval of FIRVANQ™ for treatment of clostridium difficile associated diarrhea (CDAD) and Staphylococcus aureus colitis https://www.prnewswire.com/news-releases/cutispharma-announces-fda-approval-of-firvanq-for-treatment-of-clostridium-difficile-associated-diarrhea-cdad-and-staphylococcus-aureus-colitis-300589208.html 

8:00 MedyMatch receives expedited access pathway / breakthrough device designation from the FDA to accelerate market access for intracranial hemorrhage software https://www.prnewswire.com/news-releases/medymatch-receives-expedited-access-pathway--breakthrough-device-designation-from-the-fda-to-accelerate-market-access-for-intracranial-hemorrhage-software-300588524.html 9:40 CardiAMP cell therapy receives FDA approval for pivotal trial in chronic myocardial ischemia https://www.businesswire.com/news/home/20180129006263/en/CardiAMP-Cell-Therapy-Receives-FDA-Approval-Pivotal 

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