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Monday, February 22, 2021

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

 * 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 US 

https://www.reuters.com/article/brief-astrazeneca-to-withdraw-imfinzi-us/brief-astrazeneca-to-withdraw-imfinzi-us-indication-for-advanced-bladder-cancer-idUSASN000UTX

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