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Flatiron

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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

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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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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

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Real-world evidence: breaking boundaries in rare disease

Generating data for drug launches is a challenging process. In rare diseases, with small patient populations and high unmet need, evidence generation is even more complex. Consultant Sarah Poole and...

Blue Latitude Health

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Unpacking rare diseases in the first edition of Delta magazine

Fishawack Health launches Delta magazine with a deep dive into rare disease commercialization

Blue Latitude Health

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Janet Woodcock named acting commissioner of the FDA

President Biden is set to formally nominate a commissioner soon

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BMS aims for US approval of Opdivo combo in stomach cancer

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

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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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Bayer’s finerenone scores FDA priority review for chronic kidney disease

FDA priority review is based on data from the phase 3 FIDELIO-DKD trial

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Roche’s tiragolumab plus Tecentriq combo wins FDA breakthrough therapy designation

Swiss pharma is aiming for approval in first-line NSCLC

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FDA will not alter dosing schedules for authorised COVID-19 vaccines

Time period between first and second vaccines has been extended in the UK

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