Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav® (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia in Adults prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.
Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia in Adults finanznachrichten.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from finanznachrichten.de Daily Mail and Mail on Sunday newspapers.
Sensorion Appoints Gene Therapy and Rare Disease Expert Nora Yang as Chief Scientific Officer streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.
Biom Therapeutics Receives Orphan Drug Status for BIO017 from the U.S. FDA for the treatment of Angelman Syndrome prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.
Wednesday, December 23, 2020
In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug Administration (FDA) has continued to make substantial progress on its non-COVID priorities as well.
Continued Progress on Non-COVID Priorities…
Besides the obvious scientific, technical, and regulatory work that FDA and other stakeholders have been doing all year to mount a comprehensive response to the emergence of SARS-CoV-2 as a pandemic pathogen, the agency’s work on other high-priority human drug and biological product regulatory programs continued during 2020. FDA has demonstrated a fairly impressive ability to manage a huge number of competing priorities, even as certain areas like pre-approval inspections and re-inspections of facilities seeking removal from an import alert have suffered in the face of travel restrict