158 - REC-994 for cerebral cavernous malformation; RD1 innovative device for wound management; FDA 510(k) clearance for device to monitor eyesight in AMD; low dose loteprednol; OBI-3424 for HCC; fluoroquinolones labeling; FDA Gene therapy guidance
July 12, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.co 0:35 Recursion Receives FDA Clearance of Investigational New Drug Application to Initiate First Clinical Trial of REC-994 in Cerebral Cavernous Malformation https://www.prnewswire.com/news-releases/recursion-receives-fda-clearance-of-investigational-new-drug-application-to-initiate-first-clinical-trial-of-rec-994-in-cerebral-cavernous-malformation-300678055.html 2:25 RedDress Receives FDA 510(k) Clearance for RD1 System. Innovative Device for Wound Management. https://www.prnewswire.com/news-releases/reddress-receives-fda-510k-clearance-for-rd1-system-300677736.html 3:27 Oculocare's Alleye® Receives FDA 510(k) clearance for monitoring Eyesight in AMD https://www.prnewswire.com/news-releases/oculocare-s-alleye-receives-fda-510-k-clearance-for-monitoring-eyesight-in-amd-810529944.html 5:05 Bausch + Lomb Announces U.S. FDA Filing Acceptance For Loteprednol Etabonate Ophthalmic Gel, 0.38% https://www.prnewswire.com/news-releases/bausch--lomb-announces-us-fda-filing-acceptance-for-loteprednol-etabonate-ophthalmic-gel-0-38-300677545.html 6:01 OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Hepatocellular Carcinoma (HCC) https://www.prnewswire.com/news-releases/obi-pharma-granted-fda-orphan-drug-designation-for-obi-3424-for-the-treatment-of-hepatocellular-carcinoma-hcc-300677533.html 8:11 FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reaction https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm612995.htm 10:20 Statement from FDA Commissioner Scott Gottlieb, M.D. on agency’s efforts to advance development of gene therapies https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613026.htm I have a couple of new courses on Udemy.com, which is an online platform with low cost courses in all kinds of topics. If you type in “Emma Nichols”, you’ll pull up my courses. The latest ones are Cancer Biology 101, How to Read and Interpret a Scientific Paper, and Freelance Medical Writing as a Career Choice. To check those out, just go to Udemy.com (Udemy.com) and type in “Emma Nichols” to pull them up.