Loxo-Bayer cancer drug gets priority review from FDA Ruby Khatun Khatun1 Jun 2018 9:30 AM ISTLoxo Oncology and Bayer AG said the U.S. Food and Drug Administration granted priority review to their cancer drug and would decide on the marketing...
FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients Medical Dialogues Bureau12 May 2018 12:00 PM ISTThe U.S. Food and Drug Administration today approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age...
Philippines fines Sanofi, suspends clearance for Dengvaxia Ruby Khatun Khatun5 Jan 2018 10:00 AM ISTMANILA: The Philippines has suspended clearance for Sanofi's dengue vaccine Dengvaxia and fined the French drugmaker a symbolic $2,000 citing...
Gene therapy for rare form of blindness wins US approval Ruby Khatun Khatun21 Dec 2017 10:04 AM ISTWASHINGTON: U.S. health officials on Tuesday approved the nation's first gene therapy for an inherited disease, a treatment that improves the sight of...
Aerie's glaucoma treatment gets early FDA approval Ruby Khatun Khatun20 Dec 2017 10:00 AM ISTAerie Pharmaceuticals Inc said on Monday the U.S. Food and Drug Administration approved its eyedrop, Rhopressa, as a treatment for glaucoma, two...
FDA warns companies for promoting alternatives to street drugs Ruby Khatun Khatun18 Dec 2017 10:29 AM ISTThe U.S. Food and Drug Administration (FDA) posted a warning letter to the marketers and distributors of Legal Lean Syrup, a drink, and Coco Loko, a...
Aclaris's drug to treat common skin growth gets FDA nod Ruby Khatun Khatun18 Dec 2017 10:00 AM ISTAclaris Therapeutics Inc's drug to treat a common kind of skin growth called seborrheic keratoses received approval from the U.S. Food and Drug...
FDA proposes new fast path to market for certain medical devices Ruby Khatun Khatun16 Dec 2017 10:00 AM ISTThe U.S. Food and Drug Administration on Monday proposed creating a new fast track to market for certain medical devices and a potential reduction in...
FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis Ruby Khatun Khatun15 Dec 2017 10:06 AM ISTThe U.S. Food and Drug Administration (FDA) expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis...
FDA approves Novo Nordisk diabetes drug Ozempic Ruby Khatun Khatun6 Dec 2017 10:30 AM ISTThe U.S. Food and Drug Administration on Tuesday approved Novo Nordisk A/S's diabetes drug Ozempic, setting the stage for a heated battle with Eli...
Roche's Foundation Medicine wins FDA approval for new cancer test Ruby Khatun Khatun6 Dec 2017 9:30 AM ISTZURICH: Roche on Monday said its Foundation Medicine unit won U.S. Food and Drug Administration (FDA) approval for a test to help doctors understand...
FDA moves to speed nicotine replacement product development Ruby Khatun Khatun30 Nov 2017 10:15 AM ISTThe U.S. Food and Drug Administration (FDA) said on Wednesday it is considering measures to speed development of products that help people quit...
