European Medicines Agency |

18/10/2021 COVID-19

EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11

EMA has started evaluating an application to extend the use of BioNTech/Pfizer’s COVID-19 vaccine, Comirnaty, to children aged 5 to 11. Comirnaty is a vaccine for preventing COVID-19, currently authorised for use in people aged 12 and older. It...

18/10/2021 COVID-19

New manufacturing sites and new formulation approved for COVID-19 vaccine from BioNTech/Pfizer

Additional manufacturing sites approved EMA’s human medicines committee (CHMP) has approved two additional manufacturing sites for the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. One site, located in Monza, Italy...

15/10/2021

First-in-class medicine to treat aggressive form of breast cancer

EMA has recommended granting a marketing authorisation in the European Union (EU) for Trodelvy (sacituzumab govitecan), a first-in-class medicine to treat adult patients with unresectable (cannot be removed by surgery) or metastatic triple-negative...

15/10/2021

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 October 2021

Six new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended six medicines for approval at its October 2021 meeting. Trodelvy (sacituzumab govitecan) was granted a positive opinion for the treatment of unresectable...

14/10/2021 COVID-19

EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)

EMA’s human medicines committee (CHMP) has started a rolling review of Evusheld (also known as AZD7442), a combination of two monoclonal antibodies (tixagevimab and cilgavimab), which is being developed by AstraZeneca AB for the prevention of COVID-...

12/10/2021 COVID-19

EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac AG

EMA has ended the rolling review of CVnCoV, CureVac AG’s COVID-19 vaccine, after the company informed the Agency that it was withdrawing from the process. Since February 2021, EMA’s human medicines committee (CHMP) has been reviewing data on CVnCoV...

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New manufacturing sites, formulation for Comirnaty

New manufacturing sites, formulation for Comirnaty

EMA starts evaluating Comirnaty in young children

EMA starts evaluating Comirnaty in young children

CHMP highlights: October 2021

CHMP highlights: October 2021

New application for COVID-19 treatment

New application for COVID-19 treatment

Latest news

EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11

New manufacturing sites and new formulation approved for COVID-19 vaccine from BioNTech/Pfizer

First-in-class medicine to treat aggressive form of breast cancer

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 October 2021

EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)

EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac AG

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