Regulatory
The U.S. Food and Drug Administration is putting a halt to the sale of alleged treatments for COVID-19 due to concerns about the safety risks these products could have to the public.
Novartis’ Isturisa (osilodrostat) was approved for adults with Cushing’s disease who either can’t have pituitary gland surgery or who have had the surgery but still have the disease.
Although March looks to be a busy month for the U.S. Food and Drug Administration, several of the PDUFA dates for this week were for drugs under Priority Review.
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.
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