regulatory approval

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Enhertu gets much-anticipated new FDA approval in breast cancer that expands its label and makes it an earlier option in the treatment pathway.

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Johnson & Johnson's Spravato has become the first standalone drug to be cleared by the FDA for adults with treatment-resistant depression.

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Both GSK and J&J have claimed pivotal approvals for growth-phase oncology therapies in the EU.

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AstraZeneca and Daiichi Sankyo have claimed FDA approval for a second antibody-drug conjugate for breast cancer - TROP2-directed Datroway.

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Can a new FDA approval in colorectal cancer kickstart sales growth for Amgen's KRAS inhibitor Lumakras?

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AstraZeneca's BTK inhibitor Calquence is the first drug in the class to be approved in the US for first-line treatment of mantle cell lymphoma.