Government
The FDA granted the designation based on data from a mid-stage trial that examined the safety and efficacy of Esbriet in this indication.
This approval marks the first time in a decade Sanofi has had a wholly-owned cancer drug approved.
The U.S. Department of Justice charged New Jersey-based Sandoz with four counts of conspiring to rig bids and fix prices for generic drugs.
Five years after Martin Shkreli rose to infamy for acquiring the toxoplasmosis treatment Daraprim from Impax Laboratories for $55 million and then jacking the price by 5,000%, the U.S. FDA approved the first generic for the medication.
The novel coronavirus that causes the disease COVID-19 continues to spread and has now been diagnosed in more than 50 countries.
The green light from the U.S. Food and Drug Administration marks the first approval for U.K.-based Acacia.
Eli Lilly’s Cyramza appears to be on its way to picking up its sixth approval from the U.S. Food and Drug Administration as a treatment for some lung cancer patients following narrow support from an advisory committee.
Nexlizet is expected to be on the market in the U.S. in July 2020.
A federal judge has ruled that a decade’s worth of unpublished clinical trial data from drug companies, universities and other agencies involved, must now be made public.
The agency has identified approximately 20 drugs whose active ingredients or finished products are solely sourced in China.
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