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FDA backs Moderna COVID-19 shot ahead of emergency use vote

Moderna looks odds on to claim emergency use authorisation from the FDA for its COVID-19 vaccine this week, after the regulator published a report endorsing its safety and rating its effica

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Sanofi/Regeneron on notice as FDA reviews GSK’s Nucala for n...

Sanofi and Regeneron’s Dupixent has had the US market for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) mainly to itself since June 2019, but GlaxoSmithKline’s Nucala i

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Will Gottlieb follow up on Trump's promise of a bonfire of regulations?

FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of...

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about w

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Chronic lymphocytic leukemia (CLL) is a type of cancer of the blood and bone marrow - the spongy tissue inside bones where blood cells are made.

TG Therapeutics challenges Roche with FDA filing for CLL dru...

US biotech TG Therapeutics has begun a rolling filing with the FDA for its combination therapy for chronic lymphocytic leukaemia, in a challenge to Roche.

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