Food and Drug Administration (FDA)
NEWS
Recipharm, a leading contract development and manufacturing organisation, is pleased to note the FDA’s approval of Perrigo’s AB-rated generic of ProAir HFA.
Approval for the combination treatment was based on results from the Phase I/II CheckMate-040 trial in which Opdivo and Yervoy showed an overall response rate of 33% in this patient population.
In a statement issued to the Boston Business Journal, Intarcia expressed both disappointment and a determination to get an approval for ITCA 650.
The company disclosed that the U.S. Food and Drug Administration placed a partial clinical hold on its Phase I trial for non-Hodgkin lymphoma due to a safety concern.
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.
The FDA granted the designation based on data from a mid-stage trial that examined the safety and efficacy of Esbriet in this indication.
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