Food and Drug Administration (FDA)
NEWS
In STAT News, Mary Jo Lamberti, a research fellow at the Tufts Center for the Study of Drug Development, unveiled an analysis of the amount of time it takes to initiate a clinical trial.
Analysts look at what else AbbVie has in the pipeline after Rova-T Failure.
Rheos Medicines, backed by Third Rock Ventures, launched with a $60 million Series A financing. The company will focus on immunometabolism to treat disease.
Shares of Pacira plunged more than 15 percent this morning after the company revealed the FDA panel’s decision.
Teva and Mylan are looking over their shoulders this morning after the FDA gave Novartis and Momenta the green light for their Copaxone copycat drug.
Amicus announced that the FDA accepted its NDA for migalastat to treat Fabry disease in patients with amenable mutations.
The FDA approved Gilead’s triple combination treatment for HIV, Biktarvy.
The company expected a submission date in late 2018.
Bexsero is the first vaccine in the world to receive the designation twice.
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