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- PMLiVE

chronic lymphocytic leukaemia

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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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GSK’s RSV vaccine Arexvy approved by FDA for use in adults aged 50 to 59 years

The decision comes just over a year after the FDA approved Arexvy for use in adults aged 60 years and older

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Bristol Myers Squibb’s Breyanzi receives FDA approval for mantle cell lymphoma

The rare form of non-Hodgkin lymphoma accounts for around 3% of all NHL cases

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Amgen’s interchangeable Soliris biosimilar Bkemv approved by FDA for rare blood disorders

Bkemv has been authorised to treat paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome

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Sanofi’s multiple myeloma treatment Sarclisa accepted for FDA priority review

The second most common haematologic malignancy is responsible for more than 180,000 new global diagnoses every year

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Amgen’s Imdelltra granted FDA accelerated approval to treat small cell lung cancer

More than 234,000 new cases of lung cancer are expected to be diagnosed in the US this year

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Sanofi and Sobi’s Altuviiio label updated by FDA with expanded paediatric data in haemophilia A

The therapy’s weekly dosing has a half-life of up to four times longer than current factor VIII therapies

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