April 23, 2018 / 11:47 AM / 5 months ago

BRIEF-Pfizer Provides Update On Proposed Trastuzumab Biosimilar

April 23 (Reuters) - Pfizer Inc:

* PFIZER PROVIDES UPDATE ON PROPOSED TRASTUZUMAB BIOSIMILAR

* PFIZER INC - IN CRL, FDA HIGHLIGHTED NEED FOR ADDITIONAL TECHNICAL INFORMATION

* PFIZER INC - RECEIVED CRL FROM UNITED STATES FDA IN RESPONSE TO BIOLOGICS LICENSE APPLICATION FOR COMPANY’S PROPOSED TRASTUZUMAB BIOSIMILAR

* PFIZER - ADDITIONAL REQUESTED INFORMATION BY FDA DOES NOT RELATE TO SAFETY OR CLINICAL DATA SUBMITTED IN BLA FOR CO’S PROPOSED TRASTUZUMAB BIOSIMILAR

* PFIZER - “WORKING CLOSELY” WITH FDA TO ADDRESS CONTENTS OF LETTER ON PROPOSED TRASTUZUMAB BIOSIMILAR Source text for Eikon: Further company coverage: (Reuters.Briefs@thomsonreuters.com)

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