The U.S. Food and Drug Administration approved Merck & Co. Inc.’s combination treatment for complicated forms of urinary tract and abdominal infections.
The top performers of the launch class of 2016 have very little in common – aside from the fact that none of them came from a “classic” big pharma house.
The FDA approved Gadavist for use in cardiac magnetic resonance imaging to assess myocardial perfusion and late gadolinium enhancement in adults with known or suspected CAD.
Privately held Azurity Pharmaceuticals won approval for a liquid form of a hypertension drug for both adult and pediatric patients.
Shares of Karyopharm Therapeutics skyrocketed more than 36 percent after the U.S. Food and Drug Administration approved the Newton, Mass.-based company’s Xpovio for treating multiple myeloma.
The FDA approved San Diego-based Retrophin Inc.’s 100 mg and 300 mg tablets of Thiola EC (tiopronin) to treat cystinuria.
The U.S. FDA gave Alexion Pharmaceuticals a thumbs-up for Soliris (eculizumab) to treat neuromyelitis optica spectrum disorder in adults that express a specific biomarker.
The U.S. Food and Drug Administration approved Pfizer Inc.’s biosimilar to Roche Holding AG’s blockbuster cancer treatment Avastin.
The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals Inc. and Sanofi SA’s drug Dupixent to treat nasal polyps, marking the third major use for the injectable medicine.
The U.S. FDA declined to approve Acer Therapeutics Inc.’s Edsivo for a severe, rare genetic disorder – vascular Ehlers-Danlos syndrome (vEDS) – that can cause blood vessels to fatally rupture.
The U.S. drug regulator approved Palatin Technologies and Amag Pharmaceuticals’ drug to restore sexual desire in premenopausal women.