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FDA grants priority review for Roche’s Evrysdi for spinal muscular atrophy in babies

The review of Evrysdi has been developed for pre-symptomatic babies under two months old with spinal muscular atrophy

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Gilead’s Veklury receives FDA approval for non-hospitalised high-risk patients to treat COVID-19

The FDA also issued an EUA for the treatment to include non-hospitalised paediatric patients 12 years and under who are at high risk of disease progression

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AstraZeneca’s Enhertu receives FDA grant for priority review

The approval is based on results from the DESTINY-Breast03 trial which showed a significant risk reduction of unresectable or metastatic HER-2 positive breast cancer progression

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Pfizer’s Cibinqo granted FDA approval for adults with moderate-to-severe atopic dermatitis

The FDA based its approval on results from a clinical trial programme involving over 1,600 patients

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Amgen’s Lumykras receives conditional marketing authorisation from EC

The drug is the first targeted therapy for patients diagnosed with advanced NSCLC with the KRAS G12C mutation

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Pfizer/BioNTech receives expanded authorisation from the FDA for its COVID-19 booster

The booster dose of the companies’ COVID-19 vaccine is now authorised to include individuals aged 12 years and older

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FDA rejects Takeda’s Eohilia after delays

After more than a year on ‘priority review’, the FDA has said it cannot approve Takeda’s budesonide oral suspension without a further clinical study

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FDA approves Amgen’s Otezla for all patients with plaque psoriasis

The FDA has expanded use of Otezla to adults with mild to moderate plaque psoriasis, making it the first oral treatment for the skin condition, regardless of severity

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AstraZeneca’s Saphnelo to be approved in Europe for lupus

The EMA is set to approve the first new treatment for systemic lupus erythematosus in Europe in more than a decade

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Tezspire approved in US for severe asthma

AstraZeneca and Amgen’s monoclonal antibody Tezspire is now available to control dangerous exacerbations in all adults and children aged 12 years and above with severe asthma

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FDA approves first drug to prevent graft-versus-host disease

Bristol Myers Squibb’s arthritis drug, Orencia, can now be given to adults and children undergoing stem cell transplants to prevent the life-threatening condition

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FDA approves first pre-exposure prophylactic against COVID-19

AstraZeneca’s (AZ) Evushield offers long-acting protection against COVID-19 in people who are either unable to receive or mount an insufficient response to a vaccine

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