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Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav® (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia in Adults

Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia in Adults

Sensorion Appoints Gene Therapy and Rare Disease Expert Nora Yang as Chief Scientific Officer

Biom Therapeutics Receives Orphan Drug Status for BIO017 from the U.S. FDA for the treatment of Angelman Syndrome

FDA in 2020: COVID Vaccine and OTC Ranitidine Drugs

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