FDA appeal decision found no issues with DrugSorb-ATR device safety but upheld the De Novo denial, and proposes a potential path forward for market authorization PRINCETON, N.J., Aug. 20, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, updates the regulatory status of its appeal with the U.S. Food and Drug Administration (FDA) for De Novo market authori

DEER PARK, Ill., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that members of the Company’s executive leadership team will host 1x1 meetings at the 2025 Wells Fargo Healthcare Conference being held September 3-5, 2025 in Boston, MA. To schedule a 1x1 meeting with the Company, please contact your Wells Fargo instit

HONG KONG, Aug. 20, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced the enrollment and dosing of the first patient in the pivotal Phase III clinical trial (AK104-310/COMPASSION-33) evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody developed by Akeso, in combination with chemotherapy for the perioperative treatment of resectable gastric/gastroesophageal junction (G/GEJ) adenocarcinoma. The COMPASSION-33 study represents the third Phase III tr

Icelandic venture capital firm Brunnur Ventures leads funding round to support development of breakthrough lipid nanoparticle delivery technologies BROOKLINE, MA, USA I August 19, 2025 I Axelyf, Inc., a biotechnology company developing next-generation lipid nanoparticle (LNP) delivery systems for RNA therapeutics, today announced the closing of $2.6 million in seed funding, with the potential to reach a total of $4.1 million this fall. The round was led by Brunnur Ventures GP, of Iceland, and in

SEOUL, South Korea I August 19, 2025 I On August 6, 2025, VASTHERA Co., Ltd. announced that it has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for VTB-10, its drug candidate for pulmonary arterial hypertension (PAH), a rare, life-threatening disease marked by elevated blood pressure in the lung arteries. VTB-10 is a first-in-class drug candidate developed using VASTHERA’s proprietary Redoxizyme™ platform.

Collaboration integrates VantAI’s frontier AI and structural proteomics discovery platform with Halda’s novel and clinically validated RIPTAC™ modality to unlock novel, cell-selective approaches in oncology and immunology NEW YORK, NA & NEW HAVEN, CT, USA I August 19, 2025 I VantAI, the leader in generative AI for proximity drug discovery, and Halda Therapeutics, the pioneer of RIPTAC (Regulated Induced Proximity Targeting Chimeras) therapeutics, today announced a strategic research collaboratio

KLN-1010 is the first anti-BCMA in vivo CAR-T program studied in a multi-center clinical trial KLN-1010 is administered directly to patients without apheresis, ex vivo manufacturing or lymphodepletion BOSTON, MA, USA I August 19, 2025 I Kelonia Therapeutics , Inc., a biotech company revolutionizing in vivo gene delivery, today announced that the first patient has been dosed in the inMMyCAR study, a Phase 1 clinical trial evaluating KLN-1010, a novel in vivo gene therapy that generates anti-BCMA

– Company’s second clinical-stage asset licensed from Mereo Biopharma based on novel insights generated in a mouse model of osteopetrosis – – āshibio has exclusive license to develop and commercialize vantictumab globally, excluding Europe, where Mereo retains commercial rights – – Vantictumab development program is supported by safety and biomarker data generated in previous clinical trials – BURLINGAME, CA, USA I August 19, 2025 I āshibio , a privately held, clinical-stage biotechnology compan

HAMPTON, NJ, USA I August 19, 2025 I Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported topline results from the Company’s ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus. Identifying the key drivers of EoE has challenged the field and research has suggested that mast cells could play an important role in the disease pathogenesis. Celldex designed this study to determine if barzolvolimab could deplete mucosal (intraep

Oslo, Norway, 20 August 2025 – Zelluna (OSE: ZLNA), a company pioneering allogeneic “off-the-shelf” T-cell receptor-based natural killer (TCR-NK) therapies for the treatment of cancer, announces its second quarter 2025 results today. Webcast scheduled for 20 August 2025, at 09:00 (CET). Link to webcast here. Second Quarter 2025 Business Update Highlights On track toward IND/CTA submission in 2H 2025 and first-in-human trial initiation in 1H 2026. Broadened regulatory engagement: following p