Janssen’s esketamine depression drug set for key panel voteJanssen’s potential depression treatment made from esketamine – a version of the substance notoriously used illegally as a Share XJanssen’s esketamine depression drug set for key panel votehttps://pharmaphorum.com/news/janssens-esketamine-depression-drug-set-for-key-panel-vote/
FDA clears AI wearable to monitor hospital patientsAn artificial intelligence (AI)-powered wearable, Current Health, has received clearance from the FDA for use in hospital care. Share XFDA clears AI wearable to monitor hospital patientshttps://pharmaphorum.com/news/fda-clears-ai-wearable-to-monitor-hospital-patients/
Daiichi gets speedy FDA review for rare cancer drugDaiichi Sankyo has been given a priority review from the FDA for pexidartinib, which is vying to become Share XDaiichi gets speedy FDA review for rare cancer drughttps://pharmaphorum.com/news/daiichi-speedy-fda-review-rare-cancer-drug/
FDA publishes premarket guidance on combination productsThe FDA has published new premarket guidance on efficient development and review of combination products, which often combine Share XFDA publishes premarket guidance on combination productshttps://pharmaphorum.com/news/fda-publishes-premarket-guidance-on-combination-products/
Alkermes rebuffed by FDA on antidepressantAlkermes is facing a significant delay for its ALKS 5461 candidate for major depressive disorder after the FDA Share XAlkermes rebuffed by FDA on antidepressanthttps://pharmaphorum.com/news/alkermes-rebuffed-by-fda-on-antidepressant/
FDA under fire from own adviser over opioid policyAn adviser to the FDA has said that the organisation is at war with itself over its policy Share XFDA under fire from own adviser over opioid policyhttps://pharmaphorum.com/news/fda-under-fire-from-own-adviser-over-opioid-policy/
Market access roundup: The US fights back against price hikesDon’t expect the US government’s war on drug pricing to go away any time soon – for once Share XMarket access roundup: The US fights back against price hikeshttps://pharmaphorum.com/views-analysis-market-access/market-access-roundup-the-us-fights-back-against-price-hikes/
FDA decisions could ‘slow to crawl’ because of government shutdownExperts have said the ongoing government shutdown may already have delayed approval and launch of new drugs, as Share XFDA decisions could ‘slow to crawl’ because of government shutdownhttps://pharmaphorum.com/news/fda-decisions-could-slow-to-crawl-because-of-government-shutdown/
FDA advisers divided on Sanofi’s oral type 1 diabetes drugThe future of Sanofi and Lexicon’s oral diabetes drug Zynquista hangs in the balance after an FDA advisory Share XFDA advisers divided on Sanofi’s oral type 1 diabetes drughttps://pharmaphorum.com/news/fda-divided-on-sanofis-oral-type-1-diabetes-drug/
