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Sobi

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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

- PMLiVE

Sanofi’s investigational frexalimab shows promise in relapsing forms of MS

Results from a mid-stage of the candidate were recently published in the NEJM

- PMLiVE

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

- PMLiVE

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

- PMLiVE

Sanofi presents positive results for Pompe disease enzyme replacement therapy

The rare genetic disorder is estimated to affect around one in every 40,000 people in the UK

- PMLiVE

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

- PMLiVE

Sobi receives NICE recommendation for Zynlonta in two non-Hodgkin lymphomas

Over 10,000 people are diagnosed with a type of non-Hodgkin lymphoma every year in the UK

- PMLiVE

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

- PMLiVE

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

- PMLiVE

Sanofi expands rare disease pipeline with $2.2bn Inhibrx acquisition

The deal includes a mid-stage candidate for alpha-1 antitrypsin deficiency

- PMLiVE

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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