regulatory approval

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Graphic representation of an implant into an eyeball

FDA expands label for Roche's eye disease implant Susvimo

The renaissance of Roche's refillable ophthalmic implant Susvimo has continued with FDA approval for use in patients with diabetic macular oedema.

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Boost to Enhertu's prospects as FDA clears Roche diagnostic

Roche gets the first FDA approval for a diagnostic test for HER2-ultralow breast cancer, now on the label of AstraZeneca and Daiichi Sankyo's Enhertu.

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Vertex bags FDA okay for its non-opioid pain drug

Vertex gets FDA approval for its non-opioid pain drug suzetrigine, the first new class of pain medicine in the US in more than 20 years.

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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.

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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.

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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.

FDA expands label for Roche's eye disease implant Susvimo

Boost to Enhertu's prospects as FDA clears Roche diagnostic

Vertex bags FDA okay for its non-opioid pain drug

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

GBL joins CVC in €10.7bn takeover bid for Recordati

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regulatory approval

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