Approvals

US FDA grants priority review to tezepelumab to treat asthma patients

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) and granted priority review for tezepelumab, which is being developed by AstraZeneca and Amgen, to treat patients with asthma.

AstraZeneca receives European Commission clearance for Alexion acquisition

The European Commission has cleared AstraZeneca’s proposed acquisition of Alexion Pharmaceuticals for $39bn.

Seres, Nestlé to commercialise oral microbiome therapeutic in Canada and US

Seres Therapeutics and Nestlé Health Science have signed an agreement to jointly commercialise SER-109, an investigational oral microbiome therapy, in the US and Canada.

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).

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.