12 minutes | Jun 7th 2018

149 - Neulasta biosimilar; Leukine for acute radiation syndrome; priority review for Hemlibra; FDA Office of New Drug reorganization

June 7, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:50 FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609805.htm https://www.prnewswire.com/news-releases/us-fda-approves-mylan-and-biocons-fulphila-pegfilgrastim-jmdb-the-first-biosimilar-to-neulasta-300659410.html 2:18 FDA approves Leukine® (sargramostim) for the treatment of acute radiation syndrome https://www.prnewswire.com/news-releases/partner-therapeutics-ptx-announces-us-fda-approval-of-leukine-sargramostim-for-the-treatment-of-acute-radiation-syndrome-300660612.html 4:23 Roche gets priority review from FDA for Hemlibra https://www.reuters.com/article/us-roche-hemlibra/roche-gets-priority-review-from-fda-for-hemlibra-idUSKCN1J10HF https://www.roche.com/media/releases/med-cor-2018-06-05.htm 7:03 FDA's Office of New Drugs reorganization https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609647.htm http://www.pharmexec.com/fda-launches-overhaul-new-drug-review-program Brought to you by Nascent Medical. For assistance with medical writing, please email info@nascentmc.com. Music credit: freemusicarchive.org/music/MindsEye/Yellow_Taxi/  
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