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Intra-Cellular Therapeutics

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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

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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

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ICER extends evaluation of Biogen’s aducanumab after FDA delay

FDA delayed its decision on potential Alzheimer's therapy to 7 June

- PMLiVE

FDA grants emergency use for Lilly’s COVID-19 antibody drug combination

Bamlanivimab plus etesevimab shown to reduce risk of death in high-risk COVID-19 patients

- PMLiVE

FDA considers new safety warnings for Pfizer’s JAK inhibitor Xeljanz

Post-marketing study shows increased risk of serious heart-related problems and cancer with Xeljanz

- PMLiVE

FDA schedules meeting on 26 February to review J&J’s one-dose COVID-19 vaccine

Vaccine candidate demonstrated an overall efficacy of 66% in phase 3

- PMLiVE

Rolling reviews of Novavax’s COVID-19 vaccine begin across the globe

And the FDA is planning rapid reviews for COVID-19 vaccine boosters

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UPDATED: Gilead says remdesivir likely to be effective against new COVID-19 strains

FDA approved the antiviral drug for the treatment of hospitalised COVID-19 patients in October 2020

- PMLiVE

Janet Woodcock named acting commissioner of the FDA

President Biden is set to formally nominate a commissioner soon

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