FzioMed spine gel wins expedited review
This article was originally published in The Gray Sheet
FzioMed's PMA for its Oxiplex spine surgery gel is accepted for expedited FDA review, the firm announces Oct. 4. The absorbable adhesion barrier is applied to the nerve root during lumbar disc surgery to reduce post-operative pain and other symptoms. According to FzioMed, FDA granted expedited review status because there are no alternative products approved in the United States. Oxiplex, cleared in Europe in 2001, is marketed outside the United States under the brands Oxiplex/SP and MediShield and has been used in more than 80,000 surgeries
You may also be interested in...
FzioMed's Oxiplex/SP anti-adhesion gel for spine surgery is "not approvable" due to its failure to adequately demonstrate a statistically significant treatment benefit in the sponsor's randomized, pivotal trial, according to FDA's Orthopaedic and Rehabilitation Devices Panel
The WHO’s new "living guideline" against remdesivir’s use in hospitalized patients notwithstanding, some key opinion leaders in India see a role for the antiviral, but underscore that COVID-19 is still in its infancy and all repurposed therapies for the disease still have a long way to go. They also see the US remdesivir studies as more robust.
Join us for a brief audio tour around the past week's major global biopharma industry developments, in this podcast version of Scrip's Five Must-Know Things.