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Home > New FDA Approvals > 095 - Verzenio new approval; First 2.0-mm DES; Arm approval for Guardian sensor 3; orphan drug approval for YS-ON-001; Mobile Health Platform for Autism; FDA rare disease day; FDA on influenza vaccine.
Podcast: New FDA Approvals
Episode:

095 - Verzenio new approval; First 2.0-mm DES; Arm approval for Guardian sensor 3; orphan drug approval for YS-ON-001; Mobile Health Platform for Autism; FDA rare disease day; FDA on influenza vaccine.
Category: Science & Medicine
Duration: 00:17:26
Publish Date: 2018-02-27 07:00:00
Description:

February 27, 2018

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1:50 Lilly receives additional FDA approval for Verzenio™ (abemaciclib), as initial treatment for advanced breast cancer https://www.prnewswire.com/news-releases/lilly-receives-additional-fda-approval-for-verzeniotm-abemaciclib-as-initial-treatment-for-advanced-breast-cancer-300604409.html

4:41 FDA approves first 2.0-mm drug-eluting stent in US https://globenewswire.com/news-release/2018/02/26/1387418/0/en/Medtronic-Launches-First-2-0-mm-Drug-Eluting-Stent-in-United-States-Designed-to-Treat-Patients-with-Small-Vessels.html 

6:36 Medtronic announces FDA approval for new arm indication for Guardian Sensor 3 http://www.cardiovascularbusiness.com/press-releases/medtronic-receives-fda-approval-new-arm-indication-guardiantm-sensor-3 

8:28 The US FDA grants Orphan Drug Designation to Yisheng Biopharma's biological product for pancreatic cancer https://www.prnewswire.com/news-releases/the-us-fda-granted-orphan-drug-designation-to-yisheng-biopharmas-biological-product-for-pancreatic-cancer-treatment-300603775.html

9:47 FDA clears mobile health platform for autism diagnosis https://globenewswire.com/news-release/2018/02/21/1372689/0/en/Cognoa-Hits-Major-Milestone-Towards-First-AI-Based-Autism-Diagnostic.html 

11:46 Taking New Steps to Meet the Challenges of Rare Diseases — FDA Marks the 11th Rare Disease Day | FDA Voice https://blogs.fda.gov/fdavoice/index.php/2018/02/taking-new-steps-to-meet-the-challenges-of-rare-diseases-fda-marks-the-11th-rare-disease-day/ 

14:33 Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s ongoing efforts to help improve effectiveness of influenza vaccines https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm598317.htm 

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