The FDA also granted traditional (full) approval to Prezista as twice-daily for use in treatment-experienced adult patients. Prezista was developed by Tibotec Pharmaceuticals and is marketed in the
Mr Geisenheimer’s appointment follows the resignation of John Schulte as president and CEO and as a director of the company. Three additional employees have also left the company.
Merit Medical Systems said that this device, which is used primarily for access to dialysis fistulas and grafts, provides several advantages for clinicians, including a marker tip to
According to the company, IntuiTrak has a novel design and deployment mechanism that simplifies delivery of the unibody bifurcated Powerlink device. The low-profile delivery system features enhanced flexibility,
The study has demonstrated a statistically significant reduction in the number of inflammatory lesions from baseline with the median reduction at three weeks after the final treatment of
The company said that the product, which has received three FDA 510(k) clearances for use in moistening, lubricating, cleaning and debriding wounds, is available to podiatrists for treatment
NeurogesX anticipates that the application, which is subject to acceptance by the FDA, will be subject to a standard review with a Prescription Drug User Fee Act date
Joel Citron, chairman of the OXiGENE board of directors, said: “The board has complete confidence in John’s ability to lead OXiGENE through its next stages of development, to
StemCor will develop the system for Hospira, and Hospira will manage the clinical trial program, leading to commercialization. The system has 510(k) clearance from the FDA and CE
Barr has filed its abbreviated new drug application (ANDA) containing a paragraph IV certification for a generic version of Opana ER with the FDA, and following receipt of
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