TherOx gets FDA panel date
This article was originally published in The Gray Sheet
Executive SummaryFDA's Circulatory System Devices Panel will meet March 18 in Gaithersburg, Md., to vote on a pre-market approval application for the firm's Aqueous Oxygen System for acute myocardial infarction patients who have undergone successful revascularization up to six hours after symptom onset. The system is used to hyperoxygenate and reinfuse a patient's blood at the infarction site
You may also be interested in...
The Swiss giant is hoping to get seven more approvals for its blockbuster immunology drug over the next 10 years.
Cadila has filed for approval of saroglitazar for NASH in India. The drug, which could emerge as the first medicine for the indication if approved, is already being used by a million Indian patients for diabetic dyslipidemia and hypertriglyceridemia.
It has been a long and sometimes tortuous development path for Lupuzor but ImmuPharma's chief executive tells Scrip the company's faith in the lupus drug is bearing fruit.