regulatory approval

News

Novartis has secured EU approval for Itvisma, a new formulation of its spinal muscular atrophy gene therapy usable in a broader patient population.

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For the first time, children in the US as young as two with blood disorders sickle cell disease and beta thalassaemia are eligible for gene therapy.

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Orca becomes a commercial-stage biotech with the approval of Tregzi, a cell therapy to prevent a serious complication of stem cell transplants.

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Viridian has fired a shot across Amgen's bows with the FDA approval of Tepezza rival Lumvoa in thyroid eye disease, a $2bn market.

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Ibrance has become the first CDK4/6 inhibitor to be approved for a challenging subtype of breast cancer that is often resistant to current treatment.

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Ionis' Tryngolza has been approved for severe hypertriglyceridaemia, opening the door to what the company thinks could be a $3bn market opportunity.