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Tezspire approved in US for severe asthma

AstraZeneca and Amgen’s monoclonal antibody Tezspire is now available to control dangerous exacerbations in all adults and children aged 12 years and above with severe asthma

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FDA approves first drug to prevent graft-versus-host disease

Bristol Myers Squibb’s arthritis drug, Orencia, can now be given to adults and children undergoing stem cell transplants to prevent the life-threatening condition

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Pfizer buys Arena in $6.7bn deal to broaden immuno-inflammatory portfolio

The cash deal includes Arena’s lead candidate, etrasimod, which is currently in trials for ulcerative colitis, Crohn’s disease and atopic dermatitis

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FDA approves first pre-exposure prophylactic against COVID-19

AstraZeneca’s (AZ) Evushield offers long-acting protection against COVID-19 in people who are either unable to receive or mount an insufficient response to a vaccine

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AstraZeneca and Ionis sign $3.6bn deal for eplontersen

The liver-targeted antisense therapy is in phase 3 trials for the treatment of transthyretin amyloidosis, a systemic, progressive and fatal condition

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Keytruda gains eighth FDA approval this year

Merck’s megablockbuster Keytruda has returned to its roots with a new indication in melanoma, the therapy area where it was first approved seven years ago

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Annual COVID-19 jabs likely, says Pfizer head

Pfizer CEO predicts annual jabs will be needed to maintain a ‘very high level of protection’ against COVID-19 and emphasises the need to vaccinate children

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US regulators set to approve oral antiviral against COVID-19

The FDA looks set to authorise Merck’s molnupiravir after its advisory body recommended the antiviral treatment, while Pfizer’s Paxlovid may be next

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COVID-19 vaccines against Omicron may be fast-tracked

Regulators including the Food and Drug Administration (FDA) may treat Omicron-specific mRNA vaccines like seasonal flu vaccines, speeding up approval

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bluebird bio’s beti-cel accepted for priority review by FDA

The tough journey to approval for beta-thalassemia gene therapy (beti-cel) in the US may be coming to an end, with approval possible by 2022

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US FDA expands COVID-19 booster jabs to all adults

All Americans 18 and over are now eligible to receive a booster shot of either the Pfizer/BioNTech or Moderna COVID-19 vaccines

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US government to pay $5.3bn for Pfizer‘s Paxlovid

If approved by the FDA, the US government will purchase 10 million courses of Pfizer’s anti-COVID protease inhibitor antiviral therapy, Paxlovid, this year and into 2022

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