Abbott received approval from the U.S. Food and Drug Administration for XIENCE Sierra, the newest generation of the gold-standard XIENCE everolimus-eluting coronary stent system.
FDA Grants Breakthrough Therapy Designation for Tafamidis for the Treatment of Patients with Transthyretin Cardiomyopathy
Pfizer Inc. announced that tafamidis received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the treatment of patients with transthyretin cardiomyopathy, which is a rare, fatal and underdiagnosed condition associated with progressive heart failure.
Merck & Co.’s cancer drug Keytruda helped extend survival and prevented disease progression when tested in a late-stage study in combination with chemotherapy for a type of lung cancer.
Lilly’s Taltz Receives First U.S. FDA Approval for Label Update to Include Data for Psoriasis Involving Genital Area
Eli Lilly and Company announced that the U.S. Food and Drug Administration approved a label update for Taltz (ixekizumab) injection 80 mg/mL to include data in psoriasis involving the genital area.
Akcea Therapeutics Inc. announced that the U.S. Food and Drug Administration’s Division of Metabolism and Endocrinology Products Advisory Committee voted 12-8 to support approval of Waylivra (volanesorsen) for the treatment of people with familial chylomicronemia syndrome.
U.S. regulators said Mylan NV’s EpiPen products are in shortage, due to manufacturing delays that are creating intermittent supply constraints of the emergency allergy treatment.
Specialty pharmaceutical company AcelRx Pharmaceuticals Inc. announced the resubmission of the New Drug Application (NDA) for DSUVIA with the U.S. FDA.
An estimated 25 percent of adults in the United States will deal with some form of mental illness within a given year. It’s also estimated that many of the people who experience these problems may never report it or seek help – despite a number of available therapies.
Many restaurants, supermarkets, convenience stores and movie theaters across the United States are required to start clearly displaying food calorie counts as part of a push to trim expanding American waistlines and control healthcare costs.
U.S. Food and Drug Administration chief Scott Gottlieb questioned whether rebates that drugmakers provide to health insurers should remain protected by federal law, sparking new concerns on Wall Street over efforts to curb drug pricing.