> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-8/
- Published: 2020-05-03T12:00:00.000Z
- Updated: 2026-09-14T16:13:31.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140441

**DEVICES**

FDA has approved Roche’s cobas Plasma Separation Card, a sample collection device for HIV plasma viral load testing. Previously, plasma viral load results required blood samples to be cooled during transport to the lab. The new device allows quantitative testing of patients with HIV living in remote areas affected by extreme heat and humidity, according to the company. The card is used on Roche’s cobas 6800 and cobas 8800 molecular testing systems.

FDA has cleared a Mevion Medical Systems 510(k) clearance for the Mevion S250i Proton Therapy System that uses its Hyperscan pencil beam scanning (PBS) technology. The technology uses energy layer switching and automated collimation systems to deliver faster, sharper, and more robust PBS proton radiation treatments, the company says.

**DRUGS**

FDA has approved an Amgen supplemental BLA for Xgeva (denosumab) to expand the currently approved indication for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors to include patients with multiple myeloma. The approval is based on data from a Phase 3 study that enrolled 1,718 patients.

FDA has approved Spark Therapeutics’ Luxturna (voretigene neparvovec-rzyl), a new gene therapy to treat children and adults with an inherited form of vision loss that may result in blindness. An agency [news release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm589467.htm?ref=fdaweb.com) says that Luxturna is the first directly administered gene therapy approved in the U.S. that targets a disease caused by mutations in a specific gene.

FDA has approved La Jolla Pharmaceuticals’ Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock. An FDA [news release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm590249.htm?ref=fdaweb.com) says that in a clinical trial of 321 patients with shock and a critically low blood pressure, significantly more patients responded to treatment with Giapreza compared to those treated with placebo. “Giapreza effectively increased blood pressure when added to conventional treatments used to raise blood pressure,” FDA says.