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.
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. 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.
FDA approved Imbruvica combined with Gazyva for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma.
Hologic Inc. announced that the U.S. Food and Drug Administration granted clearance for the company’s Aptima Mycoplasma genitalium assay, the first FDA-cleared test to detect this under-recognized but increasingly common sexually transmitted infection (STI).
Abbott announced U.S. Food and Drug Administration approval of the TactiCath Contact Force Ablation Catheter, Sensor Enabled, a new ablation catheter designed to help physicians accurately and effectively treat atrial fibrillation (AFib).
The U.S. Food and Drug Administration approved a biosimilar to Roche Holding AG’s blockbuster breast cancer treatment Herceptin.
Noting that the U.S. Food and Drug Administration expects more than 200 investigational new drug applications (INDs) by 2020 per year – many of them cell and gene therapies – the regulatory agency issued an outline of new procedures planned to be implemented during 2019.