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Eli Lilly’s Omicron drug treatment gets emergency use authorisation from FDA

The drug can be used to treat adults with mild-to-moderate COVID-19, and children aged 12 or older, in specific emergency cases in non-hospital settings

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FDA accepts Priority Review for Dupixent in children with moderate-to-severe atopic dermatitis

If approved, Dupixent would be the first biologic treatment available in the US for children aged six months to five years with the skin condition

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FDA issues approval for Sanofi’s Enjaymo treatment for patients with CAD

The treatment is the first-of-its-kind for patients living with cold agglutinin disease, a rare blood disorder

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FDA issues approval for Janssen’s HIV drug Cabenuva

The injectable treatment for adults with HIV can be administered every two months

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FDA places partial clinical hold on three Gilead phase 3 trials for MDS and AML treatments

The company confirmed that six other phase 2 trials would go ahead as previously planned

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FDA restricts use of certain antibody treatments for COVID-19

The restrictions reflect recent data that shows these antibodies are not effective against the Omicron variant

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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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