AstraZeneca has failed in its bid to get US approval for its IL-5 inhibitor Fasenra as a treatment for chronic rhinosinusitis in people with nasal polyps, after the FDA rejected its marketi
Bayer has filed for approval to extend the use of its prostate cancer therapy Nubeqa as it tries to achieve labelling parity with rival drugs from Pfizer/Astellas and Johnson & Jonson,
Amryt Pharma has been handed a major blow by the FDA, after the US regulator rejected its marketing application for Oleogel-S10, its drug for rare and debilitating skin disease epidermolysi
AbbVie has filed with the FDA to extend the uses of its bipolar disorder therapy Vraylar to include adjunctive therapy for major depressive disorder, part of a plan to build sales of the dr
Manufacturing problems seem to have scuppered Mallinckrodt's hopes of bringing the first approved drug to market in the US for hepatorenal syndrome (HRS), a life-threatening condition that
It's official – President Joe Biden's choice for FDA commissioner, Robert Califf, has been confirmed to the role after a narrow 50 to 46 vote in the Senate that relied on crossover Republic