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FDA expands indication for Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys

The neuromuscular condition is estimated to affect one in every 3,500 male births worldwide

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Merck’s adult-specific pneumococcal vaccine Capvaxive granted FDA approval

The vaccine is designed to protect against the strains responsible for the majority of adult invasive pneumococcal disease

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AbbVie’s IL-23 inhibitor Skyrizi approved by FDA to treat ulcerative colitis in adults

The inflammatory bowel disease affects more than one million people in the US

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Merck’s Keytruda regimen granted FDA approval to treat endometrial cancer

Approximately 67,880 new cases of uterine cancer will be diagnosed in the US this year

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Amgen’s Blincyto approved by FDA for new acute lymphoblastic leukaemia indication

More than 6,500 new cases of the blood cancer were diagnosed in the US last year

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AstraZeneca’s Imfinzi regimen granted FDA approval to treat endometrial cancer

Mismatch repair-deficient disease accounts for up to 30% of endometrial cancer cases

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Bristol Myers Squibb’s Augtyro granted expanded FDA approval for solid tumours

The drug was approved by the US regulator last year to treat ROS1-positive NSCLC

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AstraZeneca’s Farxiga granted FDA approval to treat type 2 diabetes in paediatric patients

The chronic disease currently affects almost 30,000 people aged under 20 years in the US

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Ipsen’s Iqirvo receives FDA approval to treat adults with primary biliary cholangitis

The rare cholestatic liver disease currently affects approximately 100,000 people in the US

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Sanofi/Regeneron’s Kevzara approved by FDA for polyarticular juvenile idiopathic arthritis

The chronic disease is designated as one of the three major types of juvenile idiopathic arthritis

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Eli Lilly’s Alzheimer’s drug unanimously endorsed by FDA panel of experts

The company is seeking approval of donanemab to treat patients with early stages of the disease

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Almirall’s Klisyri receives expanded FDA approval to treat actinic keratosis

The precancerous condition is responsible for an estimated 60% of all squamous cell carcinoma cases

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