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AZ' Tagrisso first to win MHRA approval under Project Orbis
May 08, 2021AstraZeneca's Tagrisso (osimertinib), a post-surgery treatment for lung cancer, is the first drug to receive approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Project Orbis. -
Astellas and Seagen Announce U.S. FDA Acceptance of Two Supplemental Biologics License Applications for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer
April 20, 2021Astellas Pharma Inc. and Seagen Inc. announced the U.S. Food and Drug Administration (FDA) filed two supplemental Biologics License Application (sBLA) submissions for PADCEV® (enfortumab vedotin-ejfv) for review as part of the ... -
Collaborative oncology drugs review initiative announced by FDA
September 19, 2019A new initiative has already collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in three countries.
Pharma Sources Insight January 2025
