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Pfizer highlights need for fourth dose of COVID-19 vaccine to FDA

While new study published in The Lancet shows COVID-19 mortality rate is almost three times higher than previously thought

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FDA approves BMS’ Opdivo with chemotherapy for certain lung cancer patients

This is the first and only immunotherapy-based treatment approved for use before surgery for patients with non-small cell lung cancer

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bluebird bio shares therapy updates for 2022

The company provided information for its first two gene therapies and its lovo-cel BLA submission for sickle cell disease

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FDA issues final guidances for clinical cancer trials

The FDA is working to address inequities, target the right treatments to the right patients and speed progress against the most deadly and rare cancers

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Janssen and Legend Biotech’s Carvykti receives FDA approval for patients with relapsed or refractory multiple myeloma

In the study, 98% of patients with relapsed or refractory multiple myeloma responded to a one-off treatment of the drug

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FDA keeps BioMarin’s gene therapy for phenylketonuria on hold

The decision follows data suggesting BioMarin’s experimental gene therapies may have the potential to progress cancers

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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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