Regulation

Eisai-Biogen Alzheimer’s drug gets FDA breakthrough designation

Eisai and Biogen have received breakthrough therapy designation from the US Food and Drug Administration (FDA) for their Alzheimer’s disease drug candidate, lecanemab (BAN2401).

Novartis’ prostate cancer drug secures FDA breakthrough designation

Novartis has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for 177Lu-PSMA-617 to treat metastatic castration-resistant prostate cancer (mCRPC).

Mallinckrodt obtains FDA approval for StrataGraft to treat thermal burns

Mallinckrodt has received the US Food and Drug Administration (FDA) approval for StrataGraft to treat thermal burns with intact dermal elements in adults.

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.