Reuters logo
BRIEF-FDA accepts sBLA filing of soliris as potential treatment for patients with refractory generalized myasthenia gravis
March 8, 2017 / 11:51 AM / 6 months ago

BRIEF-FDA accepts sBLA filing of soliris as potential treatment for patients with refractory generalized myasthenia gravis

March 8 (Reuters) - Alexion Pharmaceuticals Inc -

* FDA accepts sBLA filing of soliris (eculizumab) as a potential treatment for patients with refractory generalized myasthenia gravis (GMG)

* FDA set a prescription drug user fee act (Pdufa) date of October 23, 2017

* U.S. FDA accepted for review company’s supplemental biologics license application to extend indication for soliris Source text for Eikon: Further company coverage:

Our Standards:The Thomson Reuters Trust Principles.
0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below