The U.S. Food and Drug Administration decided to put together an advisory committee meeting of outside experts to review a New Drug Application (NDA) for FibroGen and partner AstraZeneca’s investigational anemia therapy roxadustat.
Shares of Fujifilm Holdings Corp. fell after Kyodo news reported that so far there has been no clear evidence of efficacy for the company’s drug Avigan in treating the novel coronavirus in some clinical trials.
Japan approved Gilead Sciences Inc.’s remdesivir as a treatment for COVID-19, marking the country’s first officially authorized drug to tackle the coronavirus disease.
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.
Swiss drugmaker Roche’s push into personalized cancer medicines hit a milestone with Japanese approval of a new drug, Rozlytrek, that targets patients who must be identified via genetic profiling.
The U.S. Food and Drug Administration accepted for review Orion and Bayer’s New Drug Application for darolutamide for the treatment of non-metastatic castration-resistant prostate cancer.
Japanese scientists will test the use of human-induced pluripotent stem cells (iPS) to treat spinal cord injuries, a health ministry panel that approved the research project said.
Japan’s Shionogi and Swiss drugmaker Roche won U.S. FDA approval for Xofluza, the first new flu drug approved by the regulatory agency in nearly 20 years.
Bayer AG’s long-acting treatment for hemophilia A won a recommendation from a European Medicines Agency (EMA) panel for the treatment of the rare genetic disorder in which blood does not clot easily.
AstraZeneca won rapid regulatory approval for new uses of two of the company’s important cancer drugs in Japan.