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EMA human medicines committee (CHMP) highlights, September 2022
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 medicines for approval, including those for rare diseases, osteoporosis and cancer.
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Evusheld
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Evusheld COVID-19 therapy approved in EU
Evusheld becomes first and only long-acting antibody combination available for both prevention and treatment of COVID-19 in Europe.
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AstraZeneca’s Evusheld significantly reduces risk of developing severe COVID-19
AstraZeneca's Evusheld (tixagevimab and cilgavimab) provided clinically and statistically significant protection against progression to severe COVID-19 over placebo.
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Evusheld reduces risk of symptomatic COVID-19 in high-risk population
Phase III trial shows Evusheld (tixagevimab and cilgavimab) significantly reduces the risk of developing symptomatic COVID-19 in vulnerable populations.
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EMA human medicines committee (CHMP) meeting highlights, March 2022
The March meeting saw the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommend five medications for approval including a multiple myeloma gene therapy.
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New preventative medicine for COVID-19 authorised in UK
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has reported that Evusheld, developed by AstraZeneca, has been granted approval to help protect against the effects of COVID-19.
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FDA authorises Evusheld for COVID-19 prevention
The US Food and Drug Administration (FDA) issued an emergency use authorisation for AstraZeneca’s Evusheld for the pre-exposure prophylaxis of COVID-19.
