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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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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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GSK’s RSV vaccine granted FDA priority review for use in adults aged 50 to 59 years

Arexvy has already been approved in the US and Europe to protect those aged 60 years and older

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Valneva sells FDA priority review voucher for chikungunya vaccine for $103m

The company received a tropical disease PRV in November following the FDA’s approval of Ixchiq for the prevention of disease caused by chikungunya virus

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FDA publishes final industry guidance for CAR-T and gene therapies

The new guidance can also be applied to other genetically modified lymphocyte products, including  CAR NK cells

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Sanofi/Regeneron’s Dupixent approved by FDA for younger eosinophilic oesophagitis patients

Around 21,000 children aged under 12 years in the US are being treated for the inflammatory disease

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Johnson & Johnson’s bladder cancer drug Balversa granted full FDA approval

Urothelial carcinoma accounts for approximately 90% of bladder cancer cases

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FDA grants fast track designation to Nurix’s BTK degrader for non-Hodgkin lymphomas

CLL is one of the most common types of leukaemia in adults, with around 18,740 new cases in the US last year

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Takeda’s HyQvia granted FDA approval to treat rare neuromuscular disorder CIDP

Approximately five to seven people per 100,000 in the US are affected by the disorder

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Sanofi/Regeneron’s Dupixent gets US label update for atopic dermatitis

Dupixent’s label now includes data supporting its use in hand and foot atopic dermatitis

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