The U.S. Food and Drug Administration (FDA) cleared Able Medical Devices’ thoracic fixation system called Valkyrie, a breakthrough and fully disposable bioactive sternal plating system. The medical device is intended to stabilize and fixate chest wall fractures...
The U.S. Food and Drug Administration (FDA) granted MedAlliance its fourth Breakthrough Device Designation for SELUTION SLR™, a sustained limus release drug-eluting balloon (DEB) catheter, to treat atherosclerotic lesions found in native coronary arteries. MedAlliance...
The U.S. Food and Drug Administration (FDA) cleared Flexion Therapeutics’ Investigational New Drug (IND) application for FX301, a locally administered NaV1.7 inhibitor for post-operative pain. The clearance came after the FDA reviewed preclinical data that was...
The U.S. Food and Drug Administration (FDA) approved Amondys 45 (casimersen) injection from Sarepta Therapeutics for the treatment of Duchenne muscular dystrophy (DMD) in patients that have a mutation amenable to skipping exon 45. DMD is a genetic disorder that causes...
The Center for Biologics Evaluation and Research (CBER), part of the U.S. Food and Drug Administration (FDA), partially rescinded two approvals of supplemental biologics license applications (sBLAs) for recombinant factor IX products. The sBLAs were approved by the...
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