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 Pushes Designation Status for Cancer, Hemophilia Treatments
The U.S. Food and Drug Administration (FDA) is on a mission to recuperate from the review lag seen through the early phases of COVID-19 pandemic and has provided special designations for two treatments that could improve the lives of millions with recurrent...
Cybin Submits IND Application to FDA for its Phase 1/2a First-in-Human Trial of CYB003 for the Treatment of Major Depressive Disorder
Cybin Inc, a biopharmaceutical company focused on progressing effective therapeutics for patients, is submitting an Investigational New Drug application to the U.S. Food and Drug Administration for its Phase 1/2a first-in-human clinical trial evaluating CYB003, a...
Exploring the Causal Connection Between COVID-19 and Diabetes
Research involving a causal link between COVID-19 and diabetes has surfaced in a study published in The Lancet Diabetes & Endocrinology in March. Researchers gathered results showing people who suffered from COVID-19 were 40% more likely than controls to develop...
Apyx Medical Corporation Receives FDA 510(k) Clearance for the Use of Renuvion® Cosmetic Technology in Dermal Resurfacing Procedures
Apyx Medical Corporation, a manufacturer of medical devices and supplies and the innovator of Helium Plasma Technology, marketed and sold as Renuvion® and J-Plasma® in surgical markets, today announced it has received 510(k) clearance from the U.S. Food and Drug...
FDA Hits Verrica With Third CRL For Lead Drug Candidate VP-102
Verrica Pharmaceuticals has obtained its third Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its New Drug Application for its molluscum contagiosum treatment candidate VP-102. The first CRL was distributed in July 2020 as the FDA...
Inaugural Patient Injected with Vaxinia, Cancer-Killing Oncolytic Virus
Imugene and City of Hope announced this week that the first patient has initiated treatment in a revolutionary Phase I clinical trial, which will evaluate the safety and efficacy of CF33-hNIS (Vaxinia), a cancer-killing virus, in adults with advanced tumors. The...
Altamira Therapeutics Receives Philippines’ FDA Approval of Bentrio Nasal Spray
Altamira Therapeutics Ltd., a company committed to developing therapeutics that address unmet medical needs, announced that Bentrio™ has been approved by the Philippines' Food and Drug Administration (FDA) and is now cleared for commercialization. The product will be...
Why Linguistic Validation for Patient Questionnaires is Important for Clinical Trials
With regulatory documentation presenting an enormous range of requisite communications and regulatory filings, why is linguistic validation for patient questionnaires such an important area of focus for international clinical trials? As an increasing number of...
Trinity Biotech Announces CE Mark of its 10-Minute Covid-19 Antigen Test
Trinity Biotech PLC has achieved a CE Mark for its 10-minute Covid-19 antigen test. Health professionals and trained users can utilize the CE mark as the company intends to launch the test throughout the European Union. The test not only displayed efficiency and...
XACT Robotics® Receives FDA Clearance for Ablation Procedures
XACT Robotics has received US Food and Drug Administration (FDA) clearance for a modification to its XACT ACE ® Robotic System, which is designed to support robotic insertion and steering of ablation probes during ablation clinical procedures. This clearance expands...
Categories
ABOUT US
CSOFT Health Sciences has over 15 years of experience providing end-to-end translation and localization solutions for all stages of the product life cycle, from pre-clinical to post-launch. We also specialize in China market access consulting services, Asian regulatory and eCTD submissions. Our operation is compliant with ISO 17100 and certified by BSI in ISO 9001:2015 and ISO 13485:2016, providing customized solutions to meet the rigorous regulatory requirements in global submission. For more information, please visit: www.csoftintl.com