Novartis will manufacture the anti-cholesterol medicine Leqvio at the company’s own plant in Austria to supply the United States as the Swiss drugmaker seeks U.S. approval that has been delayed by regulatory concerns over a contractor’s Italian facility.
Fennec Pharmaceuticals resubmitted the company’s New Drug Application (NDA) to the U.S. Food and Drug Administration for the pediatric chemotherapy-induced hearing loss prevention drug Pedmark.
Shares of Supernus Pharmaceuticals climbed in trading on April 5 after the U.S. Food and Drug Administration’s April 2 approval of the company’s non-stimulant treatment for attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age.
Heron Therapeutics Inc.’s New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration for HTX-011, an investigational agent for the management of postoperative pain.
A look at U.S. Food and Drug Administration PDUFA dates for end-of-August and early-September 2020.
GlaxoSmithKline’s HIV business ViiV is within weeks of resubmitting the request for approval of the long-acting injection Cabenuva to the U.S. drug regulator.
Wrapping up June and ahead of the July 4 holiday, the U.S. Food and Drug Administration has a busy two-week period coming up for drug approval reviews.
Correvio Pharma Corp. announced that the U.S. Food and Drug Administration accepted for review the resubmitted New Drug Application (NDA) for the antiarrhythmic drug Brinavess.
Zogenix Inc. intends to resubmit the company’s New Drug Application for Fintepla (ZX008, fenfluramine) for the treatment of seizures associated with Dravet syndrome in third-quarter 2019.