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.
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 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, 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).
The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved AstraZeneca’s Saphnelo (anifrolumab) to treat adult patients with systemic lupus erythematosus (SLE).
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).
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.
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a booster dose of Pfizer-BioNTech’s Covid-19 vaccine.
The US Food and Drug Administration (FDA) has approved Samsung Bioepis and Biogen’s Byooviz (ranibizumab-nuna), a biosimilar referencing Lucentis (ranibizumab).
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.
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