Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
FDA Approves Chiesi Global Rare Diseases’ Ferriprox for Sickle Cell Disease
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 drug use...
In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746: Five key questions answered for MedTech Companies
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...
Alzheimer’s Drug Shows Language Improvement for Fragile X Syndrome
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 that causes...
Moderna Working on Improving COVID-19 Vaccine
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;...
Parkinson’s Clinical Trial Approved by FDA
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 multiple...
Health Canada Grants Marketing Approval to Rockwell Medical for Triferic® AVNU™
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...
FDA & CDC Lift Restrictions on J&J Vaccination
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 (ACIP)...
TGA Approves Global Sarcoma Therapy
The Therapeutic Goods Administration (TGA) has approved the use of Global Sarcoma Therapy called YONDELISÒ, marketed by Specialised Therapeutics, for Australian patients afflicted with "unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior...
India Sets New World Record of COVID-19 Cases
India recorded today the highest number of COVID-19 cases in a day today (4/22) at 314,835 infections, surpassing the previous record from the United States at 297,430. The exponential rise in cases have caused fear regarding hospital oxygen supply levels to treat...
Pipeline™ Flex Embolization Device with Shield Technology™ Receives FDA Approval
The U.S. Food and Drug Administration (FDA) granted Medtronic's Pipeline™ Flex Embolization Device with Shield Technology™ regulatory approval. The Shield Technology is designed to introduce the first surface-modified implant device that reduces the tendency of the...
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