Regulatory
Glaucoma is a progressive disease of the eye that can lead to irreversible vision loss and blindness.
On Tuesday, the European Commission gave the green light to the merger following the divestiture of an investigational autoimmune treatment.
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.
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 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.
Kiadis Pharma N.V. announced the launch of a first-in-human clinical trial in patients with relapsed/refractory acute myeloid leukemia with off-the-shelf Natural Killer cells manufactured using Kiadis’ FC21 mbIL21 feeder cells and proprietary universal donor platform.
The agency has identified approximately 20 drugs whose active ingredients or finished products are solely sourced in China.
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