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PTC Announces Results of Real-World Study

PTC Announces Results of Real-World Study

PTC Therapeutics announced today the results of its real-world study for patients diagnosed with Becker muscular dystrophy (BMD) and Duchenne muscular dystrophy (DMD) who switched between prednisone to EMFLAZA® (deflazacort) after the U.S. Food and Drug...
FDA Clears Valkyrie Thoracic Fixation System

FDA Clears Valkyrie Thoracic Fixation System

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...
FDA Provides Guidance on Switches to Container Closure

FDA Provides Guidance on Switches to Container Closure

The U.S. Food and Drug Administration (FDA) provided guidance that addresses changes to the supply chain due to COVID-19, including its regulatory process for manufacturing and controls (CMS) and chemistry. Materials like glass vials, stoppers, test swabs, and...