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Intuitive and Discreet Device Provides Sacral Neuromodulation Therapy for Overactive Bladder and Bowel Incontinence
Generally speaking, the Orphan Drug Act has worked. More companies are willing to invest the millions of dollars needed to develop a drug that has a very small market.
The U.S. Food and Drug Administration approved another biosimilar. On Friday, the regulatory agency approved Herzuma, a biosimilar to Genentech’s Herceptin developed by South Korea-based Celltrion, Inc. and Israel-based Teva Pharmaceuticals.
As the holidays approach, the U.S. Food and Drug Administration (FDA) is getting in a few drug approvals to wrap up the year. This week there are two decision dates, with another that has been delayed for several months. Here’s a look.
The rule could have allowed generic manufacturers to independently update safety data on drugs, which could have opened the companies to potential lawsuits over side effects.
In writing literally hundreds of stories this year, two BioSpace writers, Alex Keown and Mark Terry, found certain stories particularly intriguing or impactful. Some of those were such big topics that they were covered over a series of stories. Looking back at 2018, here are their Top 10.
As we look back over the year, we noticed some stories just grabbed readers more than others. Here’s a look at the top 10 stories of the year, including job cuts, best-selling drugs, up-and-coming companies,scandals, clinical trials, and more.
Lawsuit Charges FDA, NIH With Failing to Follow Established Law for Reporting of Clinical Trial Data
The lawsuit alleges that the government is letting a number of researchers off the hook of reporting clinical data.
The rejection comes about a month after the painkiller was cleared by an FDA advisory committee.
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