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- PMLiVE

EMA begins rolling review of CureVac’s COVID-19 vaccine

Investigational vaccine is currently being evaluated in a phase 2/3b clinical 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

- 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

regeneron headquarters

EMA launches rolling review of Regeneron’s COVID-19 antibody cocktail

Study suggests REGN-COV2 can reduce viral load in non-hospitalised patients with COVID-19

- PMLiVE

CHMP recommends EU approval for Amarin’s cardiovascular risk reduction drug

The drug is recommended for use in adult patients who are already receiving statin treatment

- PMLiVE

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

- PMLiVE

BMS aims for US approval of Opdivo combo in stomach cancer

US regulator has set a goal date for a decision on 25 May

- PMLiVE

New dosing option for AZ’s Imfinzi approved in the EU and UK

Additional option extends dosing from two weeks to four weeks

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