The U.S. Food and Drug Administration approved Pfizer Inc.’s biosimilar to Roche AG’s blockbuster breast cancer treatment Herceptin.
There were as many billion-dollar brands in 2017 as there have been in any other calendar year despite the cratering effects of massive patent cliffs in 2012 and 2015.
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 U.S. Food and Drug Administration approved expanded use of Regeneron Pharmaceuticals Inc. and Sanofi SA’s eczema drug Dupixent to include patients aged between 12 and 17 years.
The U.S. FDA approved Johnson & Johnson’s nasal spray antidepressant Spravato for people resistant to other treatments, but placed restrictions on use of the drug.
The U.S. FDA approved Bausch + Lomb’s Lotemax SM (loteprednol etabonate ophthalmic gel) 0.38%, a new gel formulation for treating postoperative inflammation and pain following ocular surgery.
The U.S. Food and Drug Administration gave Janssen Biotech and the Johnson & Johnson company’s research partner Genmab an approval for their Darzalex split-dosing regimen.
The U.S. FDA approved Cablivi in combination with plasma exchange and immunosuppression for treating acquired thrombotic thrombocytopenic purpura (aTTP) in adults.
An injection to treat forehead wrinkles is set to rival Allergan plc’s Botox after U.S. regulators approved Evolus Inc.’s cheaper treatment, sending the Newport Beach, Calif.-based company’s shares up about 5 percent.
The U.S. Food and Drug Administration rejected Sunovion Pharmaceuticals’ experimental treatment apomorphine sublingual film (APL-130277) for OFF episodes of Parkinson’s disease.
The U.S. Food and Drug Administration approved Mylan NV’s generic version of the GlaxoSmithKline-developed blockbuster asthma treatment Advair, driving shares of Mylan 7 percent higher.