March 13, 2018 / 11:10 AM / 5 months ago

BRIEF-FDA Grants Priority Review To Merck’s Supplemental Biologics License Application For Keytruda

March 13 (Reuters) - Merck & Co Inc:

* FDA GRANTS PRIORITY REVIEW TO MERCK’S SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION (SBLA) FOR KEYTRUDA® (PEMBROLIZUMAB) FOR TREATMENT OF ADVANCED CERVICAL CANCER

* FDA GRANTS PRIORITY REVIEW TO MERCK’S SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION (SBLA) FOR KEYTRUDA® (PEMBROLIZUMAB) FOR TREATMENT OF ADVANCED CERVICAL CANCER

* MERCK & CO INC - FDA HAS SET A PDUFA, OR TARGET ACTION, DATE OF JUNE 28, 2018.

* MERCK & CO INC - FDA HAS SET A PDUFA, OR TARGET ACTION, DATE OF JUNE 28, 2018

* MERCK & CO INC - SBLA FOR KEYTRUDA IS BASED IN PART ON DATA FROM PHASE 2 KEYNOTE-158 TRIAL Source text for Eikon: Further company coverage:

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