Regulation

EMA’s CHMP approves Moderna’s new Covid-19 vaccine manufacturing site in France

Biotechnology company Moderna has secured approval from the European Medicines Agency’s (EMA) committee for human medicines (CHMP) for a new Covid-19 vaccine manufacturing site in Monts, France.

Ocugen plans to seek full approval for Covaxin in US

Ocugen has announced plans to seek full approval from the US Food and Drug Administration (FDA) for Covid-19 vaccine candidate, Covaxin.

Biogen and Eisai get FDA approval for Alzheimer’s drug Aduhelm

Biogen and Eisai have secured accelerated approval from the US Food and Drug Administration (FDA) for Aduhelm (aducanumab-avwa) as the first and only new treatment for Alzheimer’s disease since 2003.

Pfizer-BioNTech Covid-19 vaccine receives UK approval for children

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has expanded the emergency use authorisation (EUA) for Pfizer and BioNTech’s Covid-19 mRNA vaccine called BNT162b2 to include use in children aged 12 to 15 years.

Pfizer-BioNTech Covid-19 vaccine gets EU authorisation for adolescents

Comirnaty is claimed to be the first Covid-19 vaccine to be authorised in the EU for use in adolescents.

Japan authorises AstraZeneca and Moderna’s Covid-19 vaccines

The Ministry of Health, Labour and Welfare (MHLW) of Japan has granted emergency use authorization for Covid-19 vaccines developed by AstraZeneca and Moderna.

US FDA approves emergency use of Pfizer-BioNTech Covid-19 vaccine in adolescents

The US Food and Drug Administration (FDA) has expanded the emergency use authorisation (EUA) for Pfizer and BioNTech’s Covid-19 vaccine to include adolescents aged 12 to 15 years.

Russia approves single dose Covid-19 vaccine Sputnik Light

The Russian Direct Investment Fund (RDIF) has announced that a single dose Covid-19 vaccine called Sputnik Light, obtained authorisation for use in the country.

ViiV begins rolling submission for cabotegravir to prevent HIV in US

ViiV Healthcare has initiated a rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for long-acting cabotegravir to prevent human immunodeficiency virus (HIV).