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.
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...
United Kingdom first to grant license for Teva’s ophthalmology biosimilar Ongavia
Teva Pharmaceutical Industries Ltd welcomes the UK Medicines & Healthcare Regulatory Agency (MHRA) decision to grant a license for Ongavia®, a biosimilar to Lucentis® (ranibizumab ), an eye injection. The United Kingdom is the first country in Europe to authorize...
Travere Therapeutics Announced FDA Acceptance and Priority Review of New Drug Application for Sparsentan for the Treatment of IgA Nephropathy
Travere Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review of its New Drug Application (NDA) under Subpart H for accelerated approval of sparsentan for the treatment of IgA nephropathy (IgAN). The FDA has...
Inmagene Receives FDA IND Clearance for a Third Generation BTK Inhibitor Targeting Immunological Diseases
Inmagene Biopharmaceuticals announce that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application for the drug candidate IMG-004, a non-covalent, reversible, third-generation Bruton Tyrosine Kinase (BTK) inhibitor, to proceed...
ONT Chosen for Comprehensive Human Genome Program
Oxford Nanopore sequencing technology is to be used by a group of researchers led by Evan Eichler, University of Washington and Danny Miller, University of Washington and Seattle Children's Hospital, to initially sequence 500 of the 1000 Genomes Project samples. Their...
Asia’s first molecular diagnostics company for women, INEX Innovate receives European CE-IVD Certification for its OvaCis(R) Rapid Test to detect cancer in ovarian cysts.
Known as a pioneer in Asia's women's and fetal health industry, Singapore-based diagnostics developer, INEX Innovate has obtained a CE mark for its lead ovarian cancer product, the OvaCis® Rapid Test. Slated to launch in the EU and Southeast Asian markets by the end...
FDA Approves Lilly and Incyte’s OLUMIANT® (baricitinib) for the Treatment of Certain Hospitalized Patients with COVID-19
Eli Lilly and Company and Incyte announced the U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or...
Clario Announces Significant Progress and Ambitious Targets in Inaugural Environmental, Social and Governance (ESG) Report
Clario, a technology company that delivers the leading endpoint solutions for decentralized (DCT), hybrid and site-based clinical trials, announced that it has released its first Environmental, Social and Governance (ESG) Report. The report highlights the progress...
Philips receives FDA 510(k) clearance for latest breakthrough high-performance MR 7700 system
Royal Philips, a global leader in health technology, announced it has received FDA 510(k) clearance for the company’s new MR 7700 3.0T MR system. This latest break-through MR innovation from Philips delivers unmatched performance and precision for both research and...
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