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Pruritus

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Takeda’s Iclusig combination granted FDA accelerated approval for rare form of leukaemia

The drug is now the first targeted therapy approved as a frontline treatment for Ph-positive ALL

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FDA approves Orchard’s Lenmeldy gene therapy for metachromatic leukodystrophy

The rare genetic disease is estimated to affect one in every 40,000 people in the US

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FDA approves Madrigal’s Rezdiffra as first drug for fatty liver disease NASH

Over six million people in the US are affected by NASH with moderate-to-advanced liver scarring

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Bristol Myers Squibb’s Breyanzi granted FDA accelerated approval for non-Hodgkin lymphomas

About 20,700 new cases of chronic lymphocytic leukaemia are expected to be diagnosed in the US this year

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BeiGene’s Tevimbra receives FDA approval to treat advanced oesophageal cancer

More than two-thirds of patients have advanced or metastatic disease at the time of diagnosis

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FDA approves Mirum’s Livmarli to treat cholestatic pruritus in rare liver disease patients

Progressive familial intrahepatic cholestasis affects one in every 50,000 to 100,000 births in the US and Europe

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Regeneron’s Praluent receives FDA approval for paediatric patients with genetic high cholesterol

Patients aged eight year or older with heterozygous familial hypercholesterolaemia will be eligible to receive the treatment

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Ipsen’s Cabometyx and BMS’ Opdivo recommended by NICE for advanced kidney cancer

The decision could benefit approximately 2,287 patients with renal cell carcinoma annually

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Bristol Myers Squibb’s Opdivo combination receives FDA approval for urothelial carcinoma

More than 83,000 news cases of bladder cancer are expected to be diagnosed in the US this year

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BeiGene’s Brukinsa granted FDA accelerated approval for advanced follicular lymphoma

Approximately 15,000 new cases of follicular lymphoma are diagnosed in the US every year

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Sandoz receives FDA approval for first denosumab biosimilars Wyost and Jubbonti

The biosimilars have been authorised for all indications covered by Amgen's reference medicines

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Johnson & Johnson’s Rybrevant granted FDA approval for lung cancer indications

The drug was previously authorised for use by the US regulator under the accelerated approval pathway

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