Regulation

BeiGene’s Brukinsa receives approval to treat mantle cell lymphoma in Russia

The Russia Ministry of Health has approved BeiGene’s Brukinsa (zanubrutinib) to treat patients with relapsed or refractory mantle cell lymphoma (MCL).

US FDA approves Oyster Point Pharma’s nasal spray for dry eye disease

The US Food and Drug Administration (FDA) has approved Oyster Point Pharma’s TYRVAYA (varenicline solution) Nasal Spray for the treatment of dry eye disease signs and symptoms.

EMA approves two new sites for making Pfizer-BioNTech’s Covid-19 vaccine

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved two additional production sites for making Pfizer-BioNTech’s Covid-19 vaccine, Comirnaty.

US FDA’s VRBPAC recommends J&J Covid-19 vaccine booster shot

The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has unanimously recommended grant of Emergency Use Authorization (EUA) for Johnson & Johnson’s (J&J) Covid-19 vaccine booster shot.

Brii Biosciences files application for EUA for BRII-196/BRII-198 therapy in US

Brii Biosciences has filed an emergency use authorization (EUA) application for its investigational SARS-CoV-2 monoclonal antibody combination therapy, BRII-196/BRII-198, to the US Food and Drug Administration (FDA).

Kite gets US FDA approval for Tecartus to treat acute lymphoblastic leukemia

Kite, a subsidiary of Gilead Sciences, has received the US Food and Drug Administration (FDA) approval for its Tecartus (brexucabtagene autoleucel) to treat patients with relapsed or refractory b-cell acute lymphoblastic leukemia (ALL).

Japanese health ministry approves AstraZeneca’s Saphnelo for systemic lupus erythematosus

The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved AstraZeneca’s Saphnelo (anifrolumab) to treat adult patients with systemic lupus erythematosus (SLE).

Amgen receives FDA approval for Repatha to treat paediatric HeFH patients

The US Food and Drug Administration (FDA) has approved Amgen’s Repatha (evolocumab) to treat paediatric patients aged ten years and above with heterozygous familial hypercholesterolemia (HeFH).

WHO adds Regeneron antibody drug cocktail to Covid-19 treatment list

The World Health Organization (WHO) has added Regeneron Pharmaceuticals and Roche's Covid-19 antibody drug cocktail to the list of treatments for Covid-19 patients.