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- PMLiVE

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

Company is seeking an emergency use authorisation in the US

- PMLiVE

Moderna announces plans for COVID-19 variant-specific booster jabs and new production targets

Company is developing variant-specific COVID-19 vaccine candidate

- 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

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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

- PMLiVE

South African variant reduces antibody levels produced by Pifzer/BioNTech’s COVID-19 vaccine

Researchers noted it is 'unclear' what effect this reduction has on the vaccine's protection against the variant

- PMLiVE

GSK launches late-stage testing of RSV vaccine candidate in older adults

Vaccine candidate was found to be well-tolerated in a phase 1/2 trial

- PMLiVE

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

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