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FDA approves first cannabis-based drug to treat epilepsy pharmaceutical-technology
June 28, 2018
UK-based GW Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its marijuana-based Epidiolex oral solution to treat seizures caused due to Lennox-Gastaut syndrome and Dravet syndrome
FDA approves automated insulin delivery and monitoring system for paediatric patients europeanpharmaceuticalreview
June 27, 2018
The FDA has approved a diabetes management device that is intended to automatically monitor glucose and provide appropriate basal insulin doses with little or no input from the user…
The first single-dose flu drug nod could be FDA’s Christmas present for Roche fiercepharma
June 27, 2018
When Shionogi got Japanese approval for its novel flu drug Xofluza (baloxavir marboxil) in February, it didn’t expect a U.S. decision in 2018. Now, an FDA priority review has made it possible for its partner Roche to get a go-ahead before New Year's.
HTX-011 for Postoperative Pain Management Receives Breakthrough Therapy Designation from FDA americanpharmaceuticalreview
June 27, 2018
Heron Therapeutics, Inc. (NASDAQ: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs
FDA Approves First Continuous Glucose Monitoring System with a Fully Implantable Glucose Sensor and Compatible Mobile App for Adults with Diabetes americanpharmaceuticalreview
June 27, 2018
The U.S. Food and Drug Administration today approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people 18 years of age and older with diabetes.
FDA Approves Automated Insulin Delivery and Monitoring System for Use in Younger Pediatric Patients americanpharmaceuticalreview
June 27, 2018
The U.S. Food and Drug Administration today expanded the approval of the MiniMed 670G hybrid closed looped system
FDA Accepts sBLA for Merck’s Keytruda as Adjuvant Therapy in Advanced Melanoma americanpharmaceuticalreview
June 27, 2018
Merck announced the U.S. Food and Drug Administration (FDA) has accepted for standard review a new supplemental Biologics License Application (sBLA) for Keytruda, Merck’s anti-PD-1 therapy
FDA Grants Priority Review to Baloxavir Marboxil for Influenza americanpharmaceuticalreview
June 27, 2018
Genentech announced the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for baloxavir marboxil as a single-dose
FDA Approves First Drug Comprised of Marijuana americanpharmaceuticalreview
June 27, 2018
The U.S. Food and Drug Administration (FDA) approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy
FDA Approves Epidiolex drugs
June 26, 2018
The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy

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