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Pruritus

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Roche receives FDA breakthrough device designation for Alzheimer’s disease blood test

Around 55 million people globally are living with dementia, which is estimated to rise to 139 million by 2050

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FDA establishes new CDER centre focused on promoting clinical trial innovation

The C3TI will give internal and external parties easier access to information on clinical trial innovation

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AstraZeneca’s Fasenra receives FDA approval for paediatric patients with severe asthma

Severe eosinophilic asthma causes inflammation in the lungs and airways of patients

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New study reveals discrepancies in FDA accelerated approval process for cancer drugs

The study looked at 46 different cancer drugs that received accelerated approvals between 2013 and 2017

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BMS and 2seventy’s multiple myeloma therapy Abecma receives expanded FDA approval

More than 35,700 new cases of the disease are expected to be diagnosed in the US this year

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J&J and Legend’s Carvykti approved by FDA for expanded multiple myeloma use

The cell therapy is the first and only BCMA-targeted therapy to be approved for this condition as early as first relapse

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AstraZeneca/Daiichi Sankyo’s Enhertu granted FDA accelerated approval for solid tumours

The ADC has been authorised to treat adults with unresectable or metastatic HER2-positive tumours

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AstraZeneca’s Voydeya granted FDA approval for rare blood disease PNH

Up to 20% of patients treated with C5 inhibitors experience clinically significant extravascular haemolysis

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Ipsen enters $900m licensing agreement for Sutro Biopharma’s ADC candidate

STRO-003 will be the first ADC candidate to be added to Ipsen’s portfolio

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FDA grants Invivyd’s Pemgarda emergency use authorisation for COVID-19 prevention

The long-acting monoclonal antibody is authorised for use in adults and adolescents

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Merck’s Winrevair granted FDA approval to treat pulmonary arterial hypertension in adults

The rare blood vessel disorder affects approximately 500 to 1,000 people in the US every year

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AstraZeneca’s Ultomiris receives FDA approval to treat rare autoimmune disease NMOSD

Neuromyelitis optica spectrum disorder is estimated to affect approximately 6,000 adults in the US

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