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Johnson and Johnson

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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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J&J’s Darzalex recommended by CHMP to treat smouldering multiple myeloma

If approved, Darzalex would be the first therapy approved in the EU for SMM

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Organon/Henlius announce EMA validation for Perjeta biosimilar HLX11

The reference medicine holds approvals for multiple HER2-positive breast cancer indications

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Rare diseases: Novartis’ Fabhalta recommended by CHMP for C3 glomerulopathy

Approximately one to two people per million worldwide are diagnosed with the ultra-rare kidney disease every year

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Rare diseases: CHMP recommends Krystal’s Vyjuvek for dystrophic epidermolysis bullosa

There is currently only one treatment authorised for the ultra-rare genetic blistering disease

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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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CHMP recommends Bavarian Nordic’s chikungunya vaccine for individuals aged from 12 years

Approximately 480,000 cases of the mosquito-borne viral disease were reported globally in 2024

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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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Gilead’s seladelpar recommended by CHMP to treat primary biliary cholangitis

The rare liver disease affects approximately 15 per 100,000 people in Europe

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GSK’s Jemperli receives positive CHMP opinion for expanded endometrial cancer use

Approximately 121,000 people are diagnosed with primary advanced or recurrent endometrial cancer each year in Europe

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