Sage Therapeutics shares were up after the company won approval for the postpartum depression treatment Zulresso (brexanalone).
The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.
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.
Novo Nordisk submitted the company’s oral semaglutide drug, a pill that management hopes will transform the diabetes market, for approval in the United States.
Swiss drugmaker Roche Holding AG’s U.S. unit Genentech Inc. won approval for the immunotherapy Tecentriq for a tough-to-treat type of lung cancer.
The U.S. Food and Drug Administration placed a partial clinical hold on all trials of AbbVie’s Venclexta for multiple myeloma, after a review of data found a higher proportion of deaths in the cancer drug arm of the late-stage study.
Eton Pharmaceuticals Inc. submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for the injectable hospital-use product candidate DS-200 via the Rolling Review process.
The FDA – looking to ease shortages triggered by several manufacturers recalling the blood pressure medicine valsartan over possible cancer risk – approved a new generic version of the drug.
U.S. President Donald Trump’s administration tapped National Cancer Institute Director Norman Sharpless to serve as acting commissioner for the Food and Drug Administration.
The U.S. Food and Drug Administration approved Pfizer Inc.’s biosimilar to Roche AG’s blockbuster breast cancer treatment Herceptin.
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.