19 minutes | Jun 1st 2018

148 - Right to try act; Xeljanz for ulcerative colitis; Baricitinib for RA; first artificial iris; AURA™ ICP Monitoring System; neuro stent device; NKTR-181 first in class opioid; Priority Review for antiepileptic drug FYCOMPA® (perampanel); TX-004HR:

June 1, 2018 0:54 Statement from FDA Commissioner Scott Gottlieb, M.D., on the signing of the Right to Try Act https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609258.htm 2:38 FDA approves new treatment for moderately to severely active ulcerative colitis https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609225.htm https://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_u_s_fda_approves_xeljanz_tofacitinib_for_the_treatment_of_moderately_to_severely_active_ulcerative_colitis 4:50 Baricitinib 2-mg tablets for the treatment of adults with moderately-to-severely active rheumatoid arthritis https://www.prnewswire.com/news-releases/fda-approves-olumiant-baricitinib-2-mg-tablets-for-the-treatment-of-adults-with-moderately-to-severely-active-rheumatoid-arthritis-300658215.html 6:12 FDA approves first artificial iris https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609291.htm 8:10 510(k) clearance for AURA™ ICP Monitoring System https://www.prnewswire.com/news-releases/branchpoint-technologies-announces-fda-510k-for-its-aura-intracranial-pressure-monitoring-system-300657454.html 9:40 FDA Approval For Neuro Stent Device https://www.prnewswire.com/news-releases/microvention-announces-fda-approval-for-neuro-stent-device-300657235.html 11:05 NDA for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Low Back Pain in Adult Patients New to Opioid Therapy https://www.prnewswire.com/news-releases/nektar-therapeutics-announces-submission-of-a-new-drug-application-to-the-us-fda-for-nktr-181-a-first-in-class-investigational-opioid-to-treat-chronic-low-back-pain-in-adult-patients-new-to-opioid-therapy-300657081.html  12:30 Priority Review for antiepileptic drug FYCOMPA® (perampanel) CIII for pediatric patients https://www.prnewswire.com/news-releases/eisai-receives-fda-priority-review-designation-for-fycompa-perampanel-ciii-pediatric-indications-supplemental-new-drug-application-snda-300656500.html 13:50 FDA Approval of TX-004HR: IMVEXXY™ (estradiol vaginal inserts), the Lowest Dose Vaginal Estrogen Product Approved for the Treatment of Moderate to Severe Dyspareunia, a Symptom of VVA, due to Menopause https://www.prnewswire.com/news-releases/therapeuticsmd-announces-fda-approval-of-tx-004hr-imvexxy-estradiol-vaginal-inserts-the-lowest-dose-vaginal-estrogen-product-approved-for-the-treatment-of-moderate-to-severe-dyspareunia-a-symptom-of-vva-due-to-menopause-300656468.html 14:50 clearance of IND application on CAR-T immuno-cell therapy for the Treatment of Multiple Myeloma https://www.prnewswire.com/news-releases/legend-announces-fda-clearance-of-ind-application-on-car-t-immuno-cell-therapy-for-the-treatment-of-multiple-myeloma-300656364.html 16:30 As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609188.htm Music credit: freemusicarchive.org/music/MindsEye/Yellow_Taxi/    
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