regulatory approval

News

Ozempic is first GLP-1 drug FDA-approved for kidney disease

Novo Nordisk's Ozempic has become the first drug in the GLP-1 class to be cleared to prevent worsening kidney disease in type 2 diabetics.

News

Enhertu gets first okay for HER2-ultralow breast cancer

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

News

J&J's Spravato gets another lift with new FDA approval

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

News

EU approves endometrial, lung cancer drugs from GSK and J&J

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

News

AZ, Daiichi get FDA nod for Dato-DXd in breast cancer

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

News

Amgen picks up key colorectal cancer okay for KRAS drug

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

Ozempic is first GLP-1 drug FDA-approved for kidney disease

Enhertu gets first okay for HER2-ultralow breast cancer

J&J's Spravato gets another lift with new FDA approval

EU approves endometrial, lung cancer drugs from GSK and J&J

AZ, Daiichi get FDA nod for Dato-DXd in breast cancer

Amgen picks up key colorectal cancer okay for KRAS drug

RFK Jr revives childhood vaccine task force

The value of a partner, globally and locally

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regulatory approval

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