The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the early detection of oral and throat cancer through their proprietary mRNA technology in combination with Viome’s next-gen AI platform. The first-of-its-kind tool...
Pfizer & BioNTech’s COVID-19 vaccine is expected to receive FDA approval for adolescents ages 12 and older sometime this week. The expected approval comes from a Phase III trial in adolescents between the ages of 12 and 15 with 2,260 participants that...
Kemin Industries has announced that the U.S. Patent and Trademark Office has granted the US 10,912,794 patent on the beta 1, 3 glucan for treating inflammation in the intestine and modulating human immune function. The patent approval comes after the US 9,574,217...
The U.S. Food and Drug Administration (FDA) approved Chiesi Global Rare Diseases’ Ferriprox for treating transfusional iron overload which is caused by sickle cell disease (SCD). The treatment is approved in patients three years old and older, and expands the...
It has been almost four years since the European Commission passed the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 on May 26, 2017. With the new regulation set to be implemented in 2022, medical device manufacturers looking to market their products...
A new study published in the Nature Medicine journal has shown that Tetra Therapeutics’ Alzheimer’s investigational disease drug improves language and learning ability in adults diagnosed with Fragile X Syndrome. Fragile X Syndrome is a genetic condition...
Moderna, currently one of three companies granted emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine, is continuing its efforts in improving the vaccine. Currently, the vaccine must be stored in cold temperatures;...
The U.S. Food and Drug Administration (FDA) announced its approval of Hope Biosciences Stem Cell Research Foundation’s (HBSCRF) Phase II double blind placebo controlled Parkinson’s clinical trial. The clinical trial will test the efficacy and safety of...
Health Canada granted marketing approval today (April 27) to Rockwell Medical for its Triferic AVNU, a ferric pyrophosphate citrate injection designed to replace iron for hemoglobin maintenance in adults with hemodialysis-dependent chronic kidney disease. The drug is...
The U.S. Food and Drug Administration (FDA) and the Center for Disease Control (CDC) lifted restrictions on the single-shot Johnson & Johnson vaccination for COVID-19 this past Friday (April 23) after the FDA’s Advisory Committee on Immunization Practices...
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