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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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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 unveils new voucher programme to accelerate drug review process

The programme is designed to reduce the review time for companies supporting US national interests

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Sobi/Apellis’ pegcetacoplan shows sustained efficacy in phase 3 kidney disease study

C3G and primary IC-MPGN are estimated to affect 5,000 people in the US and up to 8,000 in Europe

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Sobi receives NICE recommendation for Altuvoct in severe haemophilia A

Approximately 7,700 people in England are living with the genetic bleeding disorder

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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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FDA approves Bavarian Nordic’s chikungunya vaccine for individuals aged from 12 years

The mosquito-borne viral disease has been reported across many popular travel destinations

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Sobi receives MHRA approval for Altuvoct in severe or moderate haemophilia A

The factor VIII replacement therapy has been authorised to treat and prevent bleeding in children and adults

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Roche’s Evrysdi tablet formulation granted FDA approval for spinal muscular atrophy

The progressive neuromuscular disease affects approximately one in every 10,000 babies globally

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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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FDA accepts updated protocol for Annovis’ phase 3 Alzheimer’s disease study

The company hopes the revised protocol will accelerate the development timeline of buntanetap

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