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The U.S. Food and Drug Administration (FDA) approved Biogen’s SPINRAZA™ (nusinersen) under Priority Review for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. SPINRAZA is the first and only treatment approved in the U.S. for SMA, a leading genetic cause of death in infants and toddlers that is marked by progressive, debilitating muscle weakness.
Cipla Ltd, a global pharmaceutical company, has yielded a final approval for its lead MDI product Fluticasone + Salmeterol (Sereflo) from UK MHRA for its partner in the UK.
GenMark Diagnostics, Inc., a leading provider of automated, multiplex molecular diagnostic testing systems, has submitted 510(k) applications to the FDA for its ePlex sample-to-answer instrument and Respiratory Pathogen Panel.
Avinger, Inc., a leading developer of innovative treatments for Peripheral Artery Disease (PAD), announced that the company has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Lightbox L250 imaging console. With this new FDA clearance, the Lightbox L250 now provides detailed measurement of vessels with a few simple taps to a touch screen, helping further improve visualization inside the vessel before, during, and after Pantheris™ Lumivascular atherectomy procedures for the treatment of PAD.
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