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FDA Accepts Letter of Intent to Qualify LSM by VCTE (FibroScan®) as First…
This is the first time the FDA is accepting the initiation of the qualification process of a non-invasive test as a reasonably likely surrogate endpoint in drug development for MASH—a progressive, advanced form of steatotic liver disease that can lead to cirrhosis, liver cancer, transplantation, or death. In a communication issued by the FDA, Frank Anania, MD, director of the Division of Hepatology and Nutrition in CDER, stated, "This proposal represents an important step toward adopting…
PR Newswire
08/09/2025
Alkermes Presents Detailed Positive Results from Vibrance-1 Phase 2 Study of…
– Company to Host Investor Webcast on Monday, Sept. 8 at 8:00 a.m. ET – – Company to Host Investor Webcast onMonday, Sept. 8at8:00 a.m. ET– DUBLIN , Sept. 8, 2025 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced detailed positive results from the Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1). Alixorexton, formerly ALKS 2680, is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in phase 2...
PR Newswire
08/09/2025
ToolGen Files Patent Infringement Lawsuit Against Lonza in the Netherlands
CASGEVY, developed by Vertex Pharmaceuticals and CRISPR Therapeutics, is the world's first gene-editing therapy approved for sickle cell disease and beta-thalassemia. It has been authorized in the United Kingdom, United States, and European Union. Under a long-term supply agreement with Vertex, Lonza manufactures CASGEVY at its Netherlands site. CASGEVY, developed by Vertex Pharmaceuticals and CRISPR Therapeutics, is the world's first gene-editing therapy approved for sickle cell disease and...
PR Newswire
08/09/2025
ONWARD Medical Receives CE Mark for ARC-EX, Enabling Commercial Launch of…
THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014)The CE Mark certification allows marketing for both clinic and home useFirst commercial sales of the ARC-EX ®System in Europe are expected in Q4 2025The CE Mark enables commercialization in the European Union and facilitates a streamlined regulatory pathway in other countries, including in the UK and Switzerland EINDHOVEN, the Netherlands, Sept...
Nasdaq GlobeNewswire
08/09/2025
Newronika Appoints Keith Carlton as Executive Chairman to Reinforce Strategic…
"We are honored to welcome Keith as our Executive Chairman," said Lorenzo Rossi, PhD, Co-Founder and CEO of Newronika. "His strategic vision, coupled with a distinguished record of scaling innovative medical technology companies, will be pivotal as we advance the clinical validation and to the commercialization of AlphaDBS, our proprietary adaptive deep brain stimulation system. This innovative platform is designed to deliver precision therapy that enhances symptom relief and…
PR Newswire
08/09/2025
Junshi Biosciences Announces the Phase 3 Study of JS005 (IL-17A) for the…
Psoriasis is a common chronic, recurrent, inflammatory, and systemic disease mediated by the immune system. Its prevalence varies significantly across different regions: the overall global prevalence of psoriasis ranges from 2.0% to 3.0%, while in China it is 0.47%. According to data released by the World Psoriasis Day Consortium, the total number of patients with psoriasis worldwide is approximately 125 million, and shows a year-on-year increasing trend. Psoriasis can be accompanied by...
Nasdaq GlobeNewswire
07/09/2025
Midea Built-In Kitchen Series Elevates the Modern Kitchen at IFA 2025
Essenza Series: Practical Elegance for Everyday Living Essenza Series: Practical Elegance for Everyday Living The Essenza Series balances contemporary aesthetics and essential functionality for young singles and couples seeking practical elegance. Its clean lines, subtle textures, and intuitive layout make the space both practical and visually appealing. Ispira Series: Refined Appearance with XPRESS Cooking Features For those who seek adaptable design and an elevated cooking...
PR Newswire
07/09/2025
Midea Showcases Transformative Innovations for 'Master Your Home' at IFA 2025
Five Suites, One Home: The New Integrated Landscape Five Suites,One Home : The New Integrated Landscape Midea's SPACE MASTER collection minimizing footprint while delivering exceptional functionality set a new benchmark for space-efficiency, while the XPRESS MASTER range was engineered to reclaim time without compromising cooking quality. The exhibition is followed by SMART MASTER and ECOMASTER technologies, where AI automates energy management and adjusts settings proactively for...
PR Newswire
06/09/2025
Lung Cancer Genetics Study Launches Open-Source Data Platform to Research…
No-cost access available to qualified researchers via open-source federated data platform Lung Cancer Genetics Study. Launched in 2024, the Lung Cancer Genetics Study aims to enroll 10,000 individuals diagnosed with lung cancer by 2027. The study already includes more than 1,200 participants and is one of the most diverse cohorts ever assembled for lung cancer genetics research.This marks a new phase in the study — with researchers now able to request access to de-identified data from...
Nasdaq GlobeNewswire
06/09/2025
Digital Health Market worth US$573.5 billion by 2030 with 23.6% CAGR |…
Download PDF Brochure: https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=45458752 Download PDF Brochure:https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=45458752 Browse in-depth TOC on "Digital Health Market" 110 - Tables 30 - Figures 400 - Pages By offering,the solutions/applications segment stands out as the largest offering within the digital health market, driven by the widespread adoption of telehealth, mHealth apps, and AI-powered...
PR Newswire
06/09/2025
Antibody Discovery Market worth US$3.54 billion by 2030 with 13.3% CAGR |…
Browse in-depth TOC on "Antibody Discovery Services Market" Browse in-depth TOC on "Antibody Discovery Services Market" 450 - Tables 60 - Figures 400 - Pages By type,the antibody discovery services market, by type, is segmented into target identification & validation, antibody engineering & optimization, antigen design & production, immunization & host management, and other services. The antibody engineering & optimization segment is expected to...
PR Newswire
06/09/2025
Publication relating to transparency notifications
REGULATED INFORMATIONPublication relating to transparency notificationsMont-Saint-Guibert(Belgium), September 5, 2025 , 10:30 pm CET / 4:30 pm ET –In accordance with article 14 of the Act of 2 May 2007 on the disclosure of large shareholdings, Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) announces that it received a transparency notification as detailed below.On September 4, 2025, Nyxoah received a transparency notification from Cochlear Limited and...
Nasdaq GlobeNewswire
05/09/2025
DBV Technologies Establishes an At-The-Market (ATM) Program on Nasdaq
DBV Technologies Establishes an At-The-Market (ATM) Program on Nasdaq DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Capital Market: DBVT) (the “Company”), a clinical-stage biopharmaceutical company, today announced that it has filed a prospectus supplement with the U.S. Securities and Exchange Commission (“SEC”) relating to an at-the-market offering (the “ATM Program”). Pursuant to this new financing program, the Company may offer and sell, including with unsolicited...
Nasdaq GlobeNewswire
05/09/2025
Disclosure of notification received from Mawer
Regulated informationNazareth (Belgium)/Rotterdam (The Netherlands), 5 September 2025 – 5:40 PM CET Disclosure of notification received from MawerPursuant to the Belgian law of 2 May 2007 regarding the disclosure of major shareholdings in listed companies, Fagron received a notification from Mawer. Notification by Mawer Investment Management LtdOn 3 September 2025, Fagron received a notification that the shareholding of Mawer Investment Management Ltd, crossed the disclosure...
Nasdaq GlobeNewswire
05/09/2025
Catheters Market worth US$45.99 billion by 2030 with 8.5% CAGR |…
To stay competitive, manufacturers are ramping up R&D efforts to create next-generation catheters with better navigation, improved biocompatibility, and greater infection resistance. Many companies are also broadening their offerings by providing integrated solutions that include design enhancements, imaging system compatibility, and catheters tailored for specific procedures. This all-in-one strategy enables them to address evolving clinical demands better and reinforce their market…
PR Newswire
05/09/2025
Hearing Aids Market is Expected to Reach US$45.68 Billion by 2031; Record a CAGR…
The report runs an in-depth analysis of market trends, key players, and future opportunities. Hearing Aids Market study focuses on an array of products that are expected to drive their growth. Check valuable insights in the Gas Turbine Market report. You can easily get a sample PDF of the report - https://www.theinsightpartners.com/sample/TIPHE100000857 Overview of Report Findings Hearing aids are sound-amplifying devices designed to help people with hearing loss by...
PR Newswire
05/09/2025
Infectious Disease Diagnostics Market worth US$42.20 billion by 2030 with 9.7%…
Browse in-depth TOC on "Infectious Disease Diagnostics Market" Browse in-depth TOC on "Infectious Disease Diagnostics Market" 537 - Tables 59 - Figures 448 - Pages By product & service,the market is segmented into reagents, kits, and consumables; instruments; and software & services. In 2024, the reagents, kits, and consumables segment accounted for the largest share of the market. The large share of this segment is attributed to the high volume of these products...
PR Newswire
05/09/2025
Glenmark Initiates a Multi-Country Phase 3 Clinical Trial for Envafolimab in…
MUMBAI, India, Sept. 5, 2025 /PRNewswire/ -- Glenmark Pharmaceuticals Ltd., a research-led, global pharmaceutical company, today announced the initiation of a multi-country (ex-China) Phase 3 Clinical Trial for Envafolimab, a novel subcutaneous PD-L1 inhibitor, in patients with resectable Stage III Non-Small Cell Lung Cancer (NSCLC) in the neoadjuvant/adjuvant setting. The Company has received approval from the Drugs Controller General of India (DCGI) to begin patient enrollment and dosing in…
PR Newswire
05/09/2025
Huadong Medicine Announces Positive Preliminary Results from a Phase Ⅰ study of…
As of July 4, 2025, a total of 29 patients were enrolled (n=1, 4, 10, 11 and 3 in the 0.3, 1.0, 1.8. 2.5 and 2.75 mg/kg dose cohorts), including 17 patients with mantle cell lymphoma (MCL), 8 patients with diffuse large B-cell lymphoma (DLBCL), and 4 patients with cHL. Most patients (21, 72.4%) had received ≥3 prior lines of anti-tumor therapy. No patient permanently discontinued treatment due to treatment related adverse events (TRAEs). In the 1.8 mg/kg and 2.5 mg/kg cohorts, 38.1% of patients…
PR Newswire
05/09/2025
'CART BP pro' Opens a New Paradigm in Blood Pressure Management, Maintaining…
Accuracy Across Positions Accuracy Across Positions OnAugust 29, ProfessorJihoon Kimof Samsung Medical Center presented "Assessing the accuracy of a ring-type cuffless blood pressure device across postures". The session was chaired by ProfessorSeok Min Kang, President of the Korean Society of Cardiology, and ProfessorEugene Yang, Chair of the American College of Cardiology (ACC) Prevention of Cardiovascular Disease Section. Professor Kim reported that CART BP pro passed the...
PR Newswire
05/09/2025
Raynor: The Air-to-Air Heat Pump Built for the North
Midea introduced Raynor – built for the North – a product tailored to Nordic conditions. Its name, meaning "wise warrior", reflects its powerful heating capabilities and smart features that maximize comfort while saving energy. The Nordic focused air-to-air heat pump was awarded the "Excellent Heating Technology Innovation Gold Award" at IFA 2025. Midea introduced Raynor – built for the North – a product tailored to Nordic conditions. Its name, meaning "wise…
PR Newswire
05/09/2025
Over 275 Duchenne Patients Enrolled in Pre-Approval Treatment Programs Around…
Duchenne is a rare genetic disorder that causes progressive muscle weakness and deterioration, primarily affecting boys, with symptoms typically beginning between ages two and three. Among the US population, only 33% of those with Duchenne have previously participated in a clinical trial. Despite the urgent need for research participation, barriers to accessing clinical trials remain considerable. According to myTomorrows' recent survey of healthcare professionals, 56% of physicians report that…
PR Newswire
05/09/2025
ZINZINO AB (PUBL.): LETTER OF INTENT TO ACQUIRE TRUVY FOR INCREASED DISTRIBUTION…
The business has a total annual turnover of approximately USD 12 million. The collaboration with Zinzino is expected to add growth through the synergies that arise in the joint networks, combined with Zinzino's test-based product concept. Profitability through the transactions will thus be able to develop well by utilizing Zinzino's existing technical platform and organization. The business has a total annual turnover of approximatelyUSD 12 million. The collaboration with Zinzino is expected...
PR Newswire
05/09/2025
Virbac : Declaration of the number of shares and voting rights 08/2025
DECLARATION OF THE NUMBER OF SHARES AND VOTING RIGHTS Information on the total number of voting rights and of shares representing the share capital (Article 223-16 of the General regulations of the French Financial Market Authority – Autorité des Marchés Financiers)Quotation place: Euronext Paris Compartiment A ISIN code: FR0000031577DateTotal number of shares representing the share capitalTotal number of voting rightsAugust, 31 20258 390 660Gross total of voting rights :...
Nasdaq GlobeNewswire
05/09/2025
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