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PTC Announces Results of Real-World Study

PTC Announces Results of Real-World Study

Mar 15, 2021 | News, Regulatory

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 Baxter’s AK 98 Hemodialysis Machine

FDA Clears Baxter’s AK 98 Hemodialysis Machine

Mar 12, 2021 | Medical Translation

Baxter International announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its Artifical Kidney 98 (AK 98) dialysis machine. The next-gen, easy-to-use, portable machine is designed to administer hemodialysis (HD) treatments. Gavin...
FDA Clears Valkyrie Thoracic Fixation System

FDA Clears Valkyrie Thoracic Fixation System

Mar 9, 2021 | News, Regulatory

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...
First CAR-T by Gilead and Kite Approved by FDA

First CAR-T by Gilead and Kite Approved by FDA

Mar 8, 2021 | Medical Translation

Gilead Sciences and Kite Pharma’s Yescarta (axicabtagene ciloleucel), the first chimeric antigen receptor (CAR) T-cell therapy approved by the U.S. Food and Drug Administration (FDA) for adult patients diagnosed with follicular lymphoma (FL). Follicular lymphoma...
FDA Provides Guidance on Switches to Container Closure

FDA Provides Guidance on Switches to Container Closure

Mar 5, 2021 | News, Regulatory

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...