FDA approval

Opdivo Approved for Melanoma

Opdivo Approved for Melanoma

The U.S. Food and Drug Administration (FDA) granted accelerated approval—three months ahead of the goal date—to Opdivo (nivolumab), a new treatment for patients with unresectable or metastatic melanoma who no longer respond to other drugs. Opdivo inhibits the PD-1 protein on cells, which obstructs the immune system from attacking melanomic tumors. It is intended for: patients who have been treated with ipilimumab; and, in the case of patients whose tumors express the BRAF V600 gene mutation, for use after treatment with ipilimumab and a BRAF inhibitor.

FDA: Safe & Effective

A glimpse inside the variety of FDA approvals awarded to medical products and what they mean for practitioners and patients.
Safe & Effective

New drugs and medical devices may be touted as FDA approved, but exactly what does that highly valued and oft-cited stamp of approval mean? It’s a question that’s sure to come up often for physicians as they consider whether to prescribe a new treatment for their patients or bring a medical device of their own design to the marketplace.

Syneron Home Use Hair Removal Device Approved

Syneron Medical has received 510(k) clearance from the United States Food and Drug Administration (www.fda.gov) to market its me Home-Use Hair Removal System to consumers. The me hair removal system is the first and only FDA cleared consumer hair removal technology that is approved for all skin tones. It is also the first home-use product featuring Syneron's proprietary elos technology—which combines intense pulse light (IPL) and radiofrequency (RF) energies—to receive FDA clearance.

FDA Approves MelaFind

The MelaFind melanoma detection system from MELA Sciences has received United States Food & Drug Administration approval following its pre-market approval application submitted to the FDA in June 2009. Earlier this year, the company received CE Mark approval from the European Union for the device, which the company plans to roll out concurrently in 2012 in Germany and the United States. “We are thrilled that our years of persistence through the development and regulatory process have paid off,” said Joseph V. Gulfo, MD, president and CEO of MELA Sciences.