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evobrutinib

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FDA grants fast track designation to AC Immune’s Alzheimer’s disease vaccine

The decision was supported by interim results from a low dose cohort of the phase 1b/2 ABATE trial

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FDA approves UCB’s Rystiggo to treat generalised myasthenia gravis

The rare autoimmune disease has a global prevalence of 100 to 350 cases per every one million people

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Pfizer’s Litfulo approved by FDA as first treatment for adolescents with severe alopecia areata

Almost 20% of patients with the autoimmune disease are diagnosed before the age of 18

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FDA grants accelerated approval to Sarepta’s Duchenne muscular dystrophy gene therapy

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

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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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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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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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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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