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Merck Granted Label Expansion by FDA for Keytruda

Merck Granted Label Expansion by FDA for Keytruda

Mar 24, 2021 | News, Regulatory

Keytruda, Merck’s checkpoint inhibitor, has been granted label expansion by the U.S. Food and Drug Administration (FDA) for first-line treatment for patients diagnosed with, regardless of PD-L1 expression, locally advanced or metastatic gastroesophageal or...
FDA Provides Smooth Pathway for COVID-19 Screening Tests

FDA Provides Smooth Pathway for COVID-19 Screening Tests

Mar 19, 2021 | News, Regulatory

The U.S. Food and Drug Administration (FDA) is providing further guidance and a smoother path for COVID-19 screening tests, specifically for asymptomatic patients. Part of this process includes the release of a fact sheet for those interested in organizing screening...
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...