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Invivyd working with FDA towards potential Biologics License Application for COVID-19

The company plans head-to-head safety evaluation with COVID-19 vaccine, pending regulatory alignment

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FDA approves Pfizer and BioNTech’s jab for COVID-19

Globally, five billion doses of the companies’ vaccine have been distributed

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FDA approves Celltrion’s Actemra biosimilar Avtozma for cytokine release syndrome

Avtozma IV now fully aligns with all indications covered by Actemra IV in the US

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Moderna’s LP.8.1-adapted COVID-19 vaccine recommended by CHMP

Global health authorities have recommended that vaccines for the 2025-2026 season should target LP.8.1

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FDA approves new presentation of Celltrion’s SteQeyma for paediatric psoriasis

The Stelara biosimilar now offers all dosage forms and strengths of its reference product

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FDA grants interchangeable designation to Celltrion’s Humira biosimilar Yuflyma

The drug is approved for inflammatory conditions such as Crohn's disease and plaque psoriasis

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FDA approves Celltrion’s denosumab biosimilars Stoboclo and Osenvelt

The drugs have been authorised for all indications covered by Amgen’s bone disease therapy

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EC approves Celltrion’s RoActemra biosimilar Avtozma for inflammatory diseases

The drug has been approved for rheumatoid arthritis, giant cell arteritis and other indications

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EC approves CSL/Arcturus’ self-amplifying mRNA COVID-19 vaccine Kostaive

Kostaive is designed to instruct the body to make more mRNA to boost immune response

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WHO urges US to ‘reconsider’ withdrawal from global health organisation

President Donald Trump said the agency mishandled the COVID-19 pandemic and other global health crises

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Sanofi receives FDA fast track designation for COVID-19/flu combination vaccines

The combined vaccine approach could simplify immunisation practices and lead to higher uptake

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Merck and Ridgeback initiate phase 3 study of COVID-19 oral antiviral in high-risk adults

Lagevrio is already available in the US under emergency use authorisation to treat certain cases of COVID-19

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