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E-Labeling for the Life Sciences Industry

E-Labeling for the Life Sciences Industry

Mar 17, 2021 | e-Labeling

There has been a drastic increase in regulations surrounding labeling for medical devices over the past decade. As our world shifts towards a more digital landscape, e-labeling, which is an electronic version of an Instruction for Use (IFU), has become more popular...
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...