Food and Drug Administration (FDA)
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Although that is good news, cancer is the second-most common cause of death in the U.S., with more than 1.7 million new cancer cases each year and more than 600,000 cancer deaths. The report notes that one of the biggest factors in decreased cancer rates are lower tobacco smoking rates.
Noting that the U.S. Food and Drug Administration (FDA) expects more than 200 investigational new drug applications (INDs) by 2020 per year, many of them cell and gene therapies, the agency issued an outline of new procedures it plans to implement this year.
Eisai Co., Ltd. and Purdue Pharma L.P. today announced that a new drug application has been submitted to the U.S. Food and Drug Administration (FDA) for lemborexant, an investigational agent for sleep-wake regulation, seeking approval for the treatment of insomnia, a sleep-wake disorder.
In 2018, the FDA approved 59 novel drugs, meaning approved new molecular entities. BioSpace analyzed new drug approvals from 2014 to 2018 to determine which companies were responsible for the most drug approvals in that period. Here’s a look.
Developing treatments to help those struggling with depression, a disorder that can lead to suicide, has become a mission for Shawn Singh, CEO of VistaGen, and his colleagues.
The FDA approved Cabometyx based on the Phase III CELESTIAL trial that showed the drug provided a statistically significant and clinically meaningful improvement in median overall survival.
Wave Life Sciences is working to get its nucleic acid treatment, suvodirsen, for Duchenne muscular dystrophy (DMD) approved. DMD is a rare muscle-wasting disease that affects mostly boys, about 15,000 in the U.S.
The partial government shutdown has entered day 24 and the pharma and medtech industry is beginning to feel the impact even more, particularly as the U.S. Food and Drug Administration grows more incapable of reviewing some medications for approval.
The U.S. Food and Drug Administration (FDA) approved Bridgewater, NJ-based Amneal Pharmaceuticals’ generic version of Novartis’ Exelon Patch (Rivastigmine Transdermal System) for dementia related to Alzheimer’s and Parkinson’s diseases.
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