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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
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July 12, 2018
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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
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