BRIEF-Astrazeneca To Withdraw Imfinzi U.S. Indication For Advanced Bladder Cancer

BRIEF-Astrazeneca To Withdraw Imfinzi U.S. Indication For Advanced Bladder Cancer
Representative Image. Image Credit: Flickr
  • Country:
  • United States

AstraZeneca PLC: * ASTRAZENECA PLC - VOLUNTARY WITHDRAWAL IMFINZI US BLADDER INDICATION

* ASTRAZENECA - DECISION WAS MADE IN CONSULTATION WITH FOOD AND DRUG ADMINISTRATION * ASTRAZENECA - WITHDRAWAL DOES NOT IMPACT INDICATION OUTSIDE US

* ASTRAZENECA - WITHDRAWAL IS ALIGNED WITH FDA GUIDANCE FOR EVALUATING INDICATIONS WITH ACCELERATED APPROVALS THAT DID NOT MEET POST-MARKETING REQUIREMENTS * ASTRAZENECA - HEALTHCARE PROVIDERS ARE BEING NOTIFIED OF THIS UPDATE

* ASTRAZENECA - WITHDRAWAL DOES NOT IMPACT OTHER APPROVED IMFINZI INDICATIONS WITHIN OR OUTSIDE

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