KarenT schreef op 20 juni 2018 11:40:
Inmiddels al meer bronnen, maar wel een oudere:
The US Food and Drug Administration (FDA) has approved the filing of a supplemental Biologics License Application (sBLA) and granted a Priority Review Designation to a C1 esterase inhibitor (Cinryze, Shire) for the treatment of hereditary angioedema (HAE) in children aged 6 years and older.
The FDA is anticipating a Prescription Drug User Fee Act action date of June 20. If approved, it would become the only C1 esterase inhibitor therapy with an indication including childhood and adulthood. Shire is the only drug developer thus far that has completed a study for prophylaxis of hereditary angioedema.
www.mdmag.com/medical-news/fda-grants...Kan iemand een bevestiging vinden dat het echt vandaag plaats vind?