Government
The FDA rapidly reviewed and approved the medication under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot program.
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The approval is a first for the the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM). The drug has a list price of $225,000.
SMA is a severe neuromuscular disease caused by a mutation in the SMN1 gene, which codes for SMN, a protein necessary for motor neuron function.
Curbing the opioid crisis will continue to be a key focus for the FDA. Ned Sharpless talked about new packaging rules that are expected to help stem the concerns about too many opioids on the streets.
A recent detailed inspection by the United States Department of Agriculture has again found that Primate Research Organization Alpha Genesis is in full compliance with ALL regulations and standards of the Animal Welfare Act, company officials announced.
There are plenty of great scientific research stories out this week. Here’s a look at just a few of them.
Biopharma has several unique challenges, but one of them is the patent cliff. In an industry where only about one in 10 compounds actually makes it to market on average, those drugs aren’t able to stay on the market very long before their patents end and generic competition begins.
Days after the Federal Bureau of Investigation raided the offices of Bay Area-based uBiome over allegations of illegal billing practices, the company’s board of directors placed Jessica Richman and Zac Apte, the co-founders and co-chief executive officers of the company, on administrative leave.
Dengvaxia is approved for dengue disease caused by serotypes 1-4 in people 9 through 16 years of age who are living in areas of the U.S. who have had a laboratory-documented previous infection.
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