Regulation

US FDA approves Samsung Bioepis and Biogen’s Byooviz

The US Food and Drug Administration (FDA) has approved Samsung Bioepis and Biogen’s Byooviz (ranibizumab-nuna), a biosimilar referencing Lucentis (ranibizumab).

Health Canada approves Moderna and Pfizer-BioNTech’s Covid-19 vaccines

Health Canada has granted full approval to Moderna’s Spikevax and Pfizer-BioNTech’s Comirnaty Covid-19 vaccines for use in individuals aged 12 years and above.

EMA starts booster dose data evaluation for Pfizer-BioNTech Covid-19 vaccine

The European Medicines Agency (EMA) has started evaluation of the data on a booster (third) dose for the Covid-19 vaccine, Comirnaty, developed by Pfizer and BioNTech.

US FDA accepts Teva-MedinCell’s new drug application for drug to treat schizophrenia

Teva Pharmaceuticals and MedinCell’s new drug application (NDA) for their drug, TV-46000/mdc-IRM to treat schizophrenia has been accepted by the US Food and Drug Administration (FDA).

US FDA approves expanded indication for UCB’s Briviact to treat paediatric patients

The US Food and Drug Administration (FDA) has approved an expanded indication for UCB’s Briviact (brivaracetam) CV as monotherapy or adjunctive therapy for the treatment of partial-onset seizures in paediatric patients aged one month and above.

Japan approves AstraZeneca’s Forxiga for chronic kidney disease

Forxiga, a SGLT2 inhibitor, is the first medicine to secure approval for the treatment of CKD in Japan.

Pfizer-BioNTech seek FDA approval for Covid-19 booster dose

Pfizer and its partner BioNTech are seeking approval from the US Food and Drug Administration (FDA) for their booster dose of Covid-19 vaccine, Comirnaty, for individuals aged 16 years and above.

European Commission approves AbbVie’s Rinvoq for atopic dermatitis

The European Commission (EC) has approved AbbVie's Rinvoq (upadacitinib) to treat moderate to severe atopic dermatitis in adults and adolescents aged 12 years and above who are candidates for systemic therapy.

US FDA approves Pfizer-BioNTech’s Covid-19 vaccine

The US Food and Drug Administration (FDA) has fully approved Pfizer and BioNTech’s biologics license application (BLA) for their Covid-19 vaccine, Comirnaty, for individuals aged 16 years and above.