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Amgen’s supplemental Biologics License Application for Blincyto approved by FDA

The approval for the leukaemia drug was supported by additional data from two phase 3 studies

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Pfizer’s Talzenna combination receives FDA approval for metastatic prostate cancer

Up to 20% of patients develop metastatic prostate cancer within five to seven years of diagnosis

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bluebird bio’s sickle cell gene therapy accepted for FDA priority review

The genetic disease affects approximately 100,000 people in the US

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Roche’s fixed-duration lymphoma treatment granted FDA accelerated approval

Globally around 160,000 people are diagnosed with non-Hodgkin's lymphoma each year

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FDA advisory committee backs updated COVID-19 vaccines targeting XBB variants

The XBB.1.5 variant accounted for nearly 40% of all US COVID-19 cases as of early June

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Merck’s efinopegdutide shows promise in nonalcoholic fatty liver disease

The candidate was recently granted FDA fast track designation for a severe form of NAFLD

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Ipsen’s Bylvay approved by FDA for severe itching due to Alagille syndrome

As many as 88% of patients living with the condition experience severe pruritus

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Biogen/Eisai’s Alzheimer’s drug backed by FDA advisory committee for traditional approval

Leqembi was granted accelerated approval by the FDA in January for patients with early AD

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AstraZeneca/Sanofi’s RSV antibody backed by FDA advisory committee for infants

RSV is the leading cause of hospitalisation for infants aged under one year in the US

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Pfizer’s RSV vaccine approved by FDA for older adults

RSV infections in older adults account for up to 160,000 hospitalisations each year in the US

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FDA approves Blueprint Medicines’ Ayvakit for indolent systemic mastocytosis

Ayvakit is now the first and only approved medicine designed to treat the underlying cause of the disease

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Decision date for Sarepta’s Duchenne muscular dystrophy gene therapy delayed by FDA

The disease occurs in up to one in every 5,000 newborn males worldwide

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