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Roche’s COVID-19 antibody receives FDA approval for hospitalised adults

The decision makes Actemra the first FDA-approved monoclonal antibody to treat COVID-19

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FDA lifts partial clinical hold on bluebird bio’s sickle cell gene therapy studies

The company can now resume the enrolment and treatment of patients aged two to 17 years

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Novartis receives EC approval for Pluvicto to treat adult cancer patients

Patients receiving Pluvicto plus best standard of care had a 38% reduction in the risk of death

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ICR and University of Cambridge reveal new prostate cancer prediction tool

The new study describing the model is published in the Journal of Clinical Oncology

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FDA approves updated COVID-19 boosters for children aged from six months

The Moderna and Pfizer/BioNTech boosters both target the BA.4/BA.5 omicron subvariants

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Pfizer’s RSV vaccine candidate accepted for FDA priority review for use in older adults

A phase 3 study showed the vaccine was 85.7% effective in those with three or more symptoms

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Pfizer/BioNTech submit FDA application for BA.4/BA.5 COVID-19 vaccine in children under five

The vaccine is already authorised as a booster for ages five years and older in the US and EU

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Novartis announces positive phase 3 results for prostate cancer drug Pluvicto

The study met its primary endpoint of radiographic progression-free survival

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FDA approves Rigel’s Rezlidhia for acute myeloid leukaemia

Phase 2 data showed a complete remission rate of 35% and median duration of 25.9 months

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AZ and MSD launch ‘Never Miss’ for prostate cancer awareness

Prostate cancer is often symptomless and is the second most common cancer in men globally

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FDA approves Scynexis’ Brexafemme for recurrent vulvovaginal candidiasis

The antifungal is already approved in the US for vulvovaginal candidiasis

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bluebird bio sells Rare Pediatric Disease Priority Review Voucher

The company was granted two PRVs upon the FDA approvals of Zynteglo and Skysona

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