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Xeljanz

- PMLiVE

Pfizer’s ALK inhibitor Lorbrena scores expanded FDA approval for first-line NSCLC

The European Medicines Agency is also reviewing an application for the drug

- PMLiVE

Novavax seeks FDA emergency approval for COVID-19 vaccine by May

Company is hoping FDA will review data from a UK-based trial

- PMLiVE

UK study finds Pfizer/BioNTech, AZ/Oxford vaccines reduce severe COVID-19 in older people

Data suggests vaccine is 80% effective at preventing hospitalisations in over-80s

- PMLiVE

J&J’s one-dose COVID-19 vaccine granted emergency use approval by FDA

Company has already started shipping doses of the vaccine to the US

- PMLiVE

FDA authorises flexible storage for Pfizer/BioNTech COVID-19 vaccine

Vaccine can be transported/stored at standard pharmaceutical freezer temperatures

- PMLiVE

FDA briefing document backs J&J’s one-dose COVID-19 vaccine

Company is seeking an emergency use authorisation in the US

- PMLiVE

FDA updates guidance for COVID-19 vaccine makers addressing new variants

FDA said that it expects manufacturing information for modified vaccines to remain generally the same

- PMLiVE

FDA fast-tracks review of Incyte’s Jakafi for chronic GVHD

Submission is based on results from the pivotal REACH3 study

- PMLiVE

AZ withdraws Imfinzi in the US for advanced bladder cancer after post-marketing study fail

Immunotherapy failed to hit primary endpoint in phase 3 DANUBE trial last year

- PMLiVE

Pfizer/BioNTech say their COVID-19 vaccine can be stored at warmer temperatures

New data shows vaccine can be stored at temperatures of -25°C to -15°C

- PMLiVE

Researchers suggest delaying second dose of Pfizer/BioNTech jab to protect more people

Canada-based researchers Skowronski and De Serres say first dose is ‘highly protective’

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Pfizer/BioNTech and Moderna increase COVID-19 vaccine supplies to the EU

The EU now currently has access to 2.6 billion COVID-19 vaccine doses from a range of companies

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