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...
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...
Myovant Sciences and Pfizer Provide Update on Supplemental New Drug Application (sNDA) for MYFEMBREE®
Myovant Sciences and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for MYFEMBREE® for the management of moderate to severe pain associated with endometriosis. The...
Mental Health Awareness Month: How Natural Language Processing and Linguistic Validation Can Improve Patient Outcomes in Pediatric Mental Health
Language AI that can detect medical conditions in patient data plays a pivotal role in disease detection and early diagnostics, but as these models become more advanced and target specific conditions across the spectrum of mental and physical health, what role do...
ENHERTU® Approved in the U.S. for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen
Daiichi Sankyo and AstraZeneca’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen either in the...
BeiGene Announces the Approval in China of BLINCYTO® (Blinatumomab) for Injection for Pediatric Patients with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)
BeiGene a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, announced that the China National Medical Products Administration (NMPA) has granted...
Fast Track Designation in Hand, Graphite Bio Guns for Definitive Sickle Cell Cure
San Francisco-based Graphite Bio announced that it has received Fast Track Designation from the U.S. Food and Drug Administration for its investigational therapy GPH101, which is designed to genetically treat sickle cell disease (SCD). Sickle cell disease has a high...