US FDA

FDA grants priority review to Roche’s Lunsumio for Relapsed or Refractory Follicular Lymphoma

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Novavax expects COVID vaccine targetting Omicron in fourth quarter

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US FDA flags risk of heart inflammation after Novavax COVID vaccine

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FDA withdraws approval for TG Therapeutics cancer treatment

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US FDA grants efanesoctocog alfa breakthrough therapy designation for hemophilia A

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Preparing for surprise inspections

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US FDA accepts Dupixent for priority review in adults with prurigo nodularis

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US FDA presses pause on trial for OTC version of Cialis

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US FDA declines to approve Eton Pharma’s anti-seizure drug

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US FDA grants fast track designation to Pfizer’s ervogastat/clesacostat combination to treat NASH

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