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The U.S. Food and Drug Administration today approved Cimzia (certolizumab pegol) injection for treatment of adults with a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation.
A new treatment for anxiety, depression and insomnia may be on the way now that Innovative Neurological Devices received FDA market clearance for its Cervella Cranial Electrotherapy Stimulator (CES).
The Europa Pedicle Screw System received FDA 510(k) approval at the end of March.
Luye Pharma Group has announced submission of a new drug application (NDA) to the U.S. Food and Drug Administration ("FDA") for Rykindo®, completed on March 28. Rykindo® (LY03004) Risperidone Extended-release Microsphere for Injection is expected to become the first Chinese innovative drug to receive U.S. FDA approval for marketing in the United States.
Patients living with non-radiographic axial spondyloarthritis, an often undiagnosed, chronic, painful and debilitating disease, now have an approved, clinically validated treatment
Novel, effective endobronchial valve treatment now used by physician at hospital in Philadelphia
MAVENCLAD is the first oral MS treatment to provide two years of proven efficacy with a maximum of 20 days of treatment
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The U.S. Food and Drug Administration approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism.
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The U.S. Food and Drug Administration today approved Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
A global company has had its third test cleared by the U.S. Food and Drug Administration which this month approved GenePOC’s Strep A assay, which provides in vitro diagnosis of Strep A infections within an hour.
The U.S. Food and Drug Administration estimates that nearly 6 million Americans have heart failure — the organ can’t keep up with their bodies’ needs.
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Zimmer Biomet becomes first company in the world with 510(k) clearance for Brain, Spine and Knee offerings on one robotic platform
Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA.
Label Now Includes New Data on Use of AVYCAZ for Treatment of cUTI and cIAI in Pediatric Patients 3 Months of Age and Older