Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the OrbusNeich® 1.0mm Sapphire® II PRO coronary balloon.
A new gene therapy to treat a debilitating eye disorder is one step closer to regulatory approval in Europe. Gene therapy company MeiraGTx said the European Medicines Agency granted Priority Medicines (PRIME) designation to its candidate A002 for treatment of achromatopsia.
Vertex Pharmaceuticals Incorporated (VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved SYMDEKO™ (tezacaftor/ivacaftor and ivacaftor) for treating the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or who have at least one mutation that is responsive to tezacaftor/ivacaftor. SYMDEKO is Vertex’s third medicine approved to treat the underlying cause of CF. Vertex is ready to launch SYMDEKO and will begin shipping it to pharmacies in the United States this week.
Senseonics Holdings Inc has announced that people with diabetes using the Eversense® brand Continuous Glucose Monitoring Systems, in EMEA markets now have the option to invite others to remotely view their real-time glucose readings and alerts from anywhere.
Cognoa has gained regulatory recognition for its machine learning software as a class II diagnostic medical device for autism — meaning the digital health startup is now positioned to submit an application for full FDA clearance.
Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Cosentyx® (secukinumab), the first interleukin-17A (IL-17A) antagonist approved to treat moderate to severe plaque psoriasis.1 The updated label includes Cosentyx data in moderate to severe scalp psoriasis – one of the difficult-to-treat forms of the disease, which affects approximately half of all psoriasis patients.1-3 The label update is effective in the US immediately, and is based on the proven efficacy and consistent safety profile of Cosentyx from a dedicated Phase III scalp psoriasis trial.6
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