AstraZeneca’s Triple Regulatory Wins For Enhertu, Tezspire And Ultomiris Herald Sales Boost

Across US And EU

The major has won US priority review for a commercially crucial label expansion of its breast cancer drug Enhertu while Tezspire and Ultomiris attracted positive CHMP opinions across the Atlantic.    

Dartboard with three arrows on bullseye target
The Three Regulatory Successes Mean Bigger Markets • Source: Shutterstock

AstraZeneca PLC is enjoying a trio of positive regulatory decisions, with Enhertu set to transform the breast cancer paradigm following the FDA’s decision to prioritise its label expansion review, while Tezspire and Ultomiris won EU favor.

AstraZeneca and Daiichi Sankyo Co., Ltd.’s antibody drug conjugate Enhertu (trastuzumab deruxtecan) has been granted priority review by the...

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