Pfizer and BioNTech have asked the FDA for emergency authorisation of an Omicron-targeted COVID-19 booster vaccine ahead of the planned autumn immunisation campaign in the US.
The EU regulator has started its review of Cidara Therapeutics' once-weekly antifungal rezafungin, setting up a decision next year as a new option for serious, invasive infections caused by
The European Commission has become the first regulator worldwide to approved a therapy from Gilead Sciences for people with multidrug-resistant (MDR) HIV infection that only needs to be tak
bluebird bio's Zynteglo has become the first cell-based gene therapy to be approved in the US, getting the nod from the FDA as a treatment for patients with beta thalassaemia who require re
Astellas remains on course to be the first drugmaker to bring a new non-hormonal therapy for symptoms of menopause to market, after the FDA started a review of its orally-active neurokinin-
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