Ampio Pharma's candidate therapy for knee osteoarthritis has been knocked back by the FDA, which will likely now require a new clinical trial of the drug before it will consider a review.
Teva's long haul to a turnaround of its business has been dealt a blow by the FDA, which has just declined to approve the company's long-acting formulation of schizophrenia drug risperidone
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
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