Winstgevend schreef op 19 april 2018 13:20:
Lanadelumab Regulatory Status U.S.
Food and Drug Administration (FDA) accepted Shire's biologics license application (BLA) and granted priority review for lanadelumab in February 2018. The FDA is expected to provide a decision on lanadelumab by August 26, 2018, based on the Prescription Drug User Fee Act V action date.European Medicines Agency (EMA)
validated the marketing authorization application for lanadelumab in March 2018. EMA had previously granted lanadelumab an accelerated assessment reducing the number of evaluation days required, from 210 to 150.Health Canada
accepted the New Drug Submission (NDS) for lanadelumab under Priority Review in March 2018 shortening the review timeline from 300 to 180 days.
Therapeutic Goods Administration in Australia
granted lanadelumab priority review and orphan drug designation in February 2018.
Therapeutic Products (Swissmedic)
Validates Shire’s Marketing Authorization Application (MAA) for Investigational Hereditary Angioedema (HAE) Treatment Lanadelumab
Gaat wel hard, en nieuws-technisch SLAAPT Pharming.
Zoals we gewend zijn.