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Home > New FDA Approvals > 142 - Debio 1347 for FGFR gene alteration tumors; daratumumab for newly diagnosed MM; new combo for OAB; FDA warns e-liquid companies; 'Short-term' EpiPen shortage
Podcast: New FDA Approvals
Episode:

142 - Debio 1347 for FGFR gene alteration tumors; daratumumab for newly diagnosed MM; new combo for OAB; FDA warns e-liquid companies; 'Short-term' EpiPen shortage
Category: Science & Medicine
Duration: 00:10:42
Publish Date: 2018-05-11 06:00:00
Description:

May 11, 2018

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0:46 FDA grants Fast Track Designation to Debiopharm International's Debio 1347 for the treatment of patients with unresectable or metastatic tumors with a specific FGFR gene alteration https://www.prnewswire.com/news-releases/fda-grants-fast-track-designation-to-debiopharm-internationals-debio-1347-for-the-treatment-of-patients-with-unresectable-or-metastatic-tumors-with-a-specific-fgfr-gene-alteration-682042861.html 

2:17 Janssen announces DARZALEX® (daratumumab) U.S. FDA approval for newly diagnosed patients with multiple myeloma who are transplant ineligible https://www.prnewswire.com/news-releases/janssen-announces-darzalex-daratumumab-us-fda-approval-for-newly-diagnosed-patients-with-multiple-myeloma-who-are-transplant-ineligible-300644142.html 

5:05 FDA approves supplemental New Drug Application for Myrbetriq® (mirabegron) for use in combination with solifenacin succinate for the treatment of overactive bladder symptoms https://www.prnewswire.com/news-releases/fda-approves-supplemental-new-drug-application-for-myrbetriq-mirabegron-for-use-in-combination-with-solifenacin-succinate-for-the-treatment-of-overactive-bladder-symptoms-300644079.html

6:26 FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607327.htm

8:14 'Short-term' EpiPen shortage, anticipates FDA https://www.cnn.com/2018/05/09/health/epipen-fda-drug-shortages-list-bn/index.html

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