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GSK immunotherapy

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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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GSK’s Jemperli combination recommended by NICE as first-line endometrial cancer treatment

Approximately 580 patients will now be eligible for treatment with the PD-1 inhibitor

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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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FDA awards Orphan Drug Designation to SynaptixBio for rare brain disease therapy

Isolated hypomyelination is a form of TUBB4A leukodystrophy that has been identified relatively recently

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FDA approves Allecra’s combination antibiotic Exblifep for complicated UTIs

Complicated UTIs account for approximately 19% of all healthcare-associated infections

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FDA approves Alvotech and Teva’s Simlandi as interchangeable Humira biosimilar

Simlandi is approved to treat multiple indications, including rheumatoid arthritis and Crohn’s disease

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Johnson & Johnson’s Tecvayli receives FDA approval for reduced dosing in multiple myeloma patients

More than 35,000 cases of the blood cancer are expected to be diagnosed in the US this year

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AstraZeneca’s Tagrisso combination approved by FDA for advanced lung cancer

An estimated 200,000 people in the US are diagnosed with lung cancer every year

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FDA approves Iovance’s Amtagvi as first cellular therapy for advanced melanoma

Amtagvi is now the first one-time, individualised T cell therapy to be approved in the US for a solid tumour cancer

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GSK’s Omjjara recommended by NICE to treat myelofibrosis patients with anaemia

Myelofibrosis is estimated to affect over 1,900 people in England, Wales and Northern Ireland

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Takeda’s Eohilia approved by FDA as first oral therapy for eosinophilic oesophagitis

The inflammatory disease affects around one in 2,000 people in the US

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Ipsen’s Onivyde regimen granted FDA approval to treat pancreatic cancer

Around 60,000 people are diagnosed with pancreatic adenocarcinoma in the US every year

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