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AZ’s Saphnelo receives EU approval for systemic lupus erythematosus

There are an estimated 250,000 people living with SLE in Europe and this is the first new drug to gain EU approval in over ten years

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Onyx Health Tackles Type 2 Diabetes with Diabetes Lifestyle Doctors

Onyx Health has teamed up with Diabetes Lifestyle Doctors to tackle the diabetes care gap in the NHS and help patients suffering from type 2 diabetes across the UK. (Pictured...

Onyx Health

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Eli Lilly’s Omicron drug treatment gets emergency use authorisation from FDA

The drug can be used to treat adults with mild-to-moderate COVID-19, and children aged 12 or older, in specific emergency cases in non-hospital settings

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FDA accepts Priority Review for Dupixent in children with moderate-to-severe atopic dermatitis

If approved, Dupixent would be the first biologic treatment available in the US for children aged six months to five years with the skin condition

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FDA issues approval for Sanofi’s Enjaymo treatment for patients with CAD

The treatment is the first-of-its-kind for patients living with cold agglutinin disease, a rare blood disorder

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NICE recommends AZ’s Forxiga for kidney disease

The recommendation is based on results from a phase 3 trial

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FDA issues approval for Janssen’s HIV drug Cabenuva

The injectable treatment for adults with HIV can be administered every two months

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Lilly reveals $1bn investment in US manufacturing site

The company also plans to invest $500m in a new biopharmaceutical manufacturing facility in Ireland

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FDA places partial clinical hold on three Gilead phase 3 trials for MDS and AML treatments

The company confirmed that six other phase 2 trials would go ahead as previously planned

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FDA restricts use of certain antibody treatments for COVID-19

The restrictions reflect recent data that shows these antibodies are not effective against the Omicron variant

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FDA grants priority review for Roche’s Evrysdi for spinal muscular atrophy in babies

The review of Evrysdi has been developed for pre-symptomatic babies under two months old with spinal muscular atrophy

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Gilead’s Veklury receives FDA approval for non-hospitalised high-risk patients to treat COVID-19

The FDA also issued an EUA for the treatment to include non-hospitalised paediatric patients 12 years and under who are at high risk of disease progression

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