Medical/Pharmaceuticals
Grit Biotechnology Presents Clinical Breakthroughs at 2025 ASCO Annual Meeting
SHANGHAI, May 29, 2025 /PRNewswire/ -- Grit Biotechnology Co., Ltd. ("Grit Bio "), a clinical-stage biotech pioneering novel immunotherapies announced today that three abstracts featuring new clinical data from tumor-infiltrating lymphocytes (TIL) therapies will be presented at the American Societ...
2025-05-29 20:30
1818
AccurEdit Therapeutics' ART001 Becomes China's First Gene Editing Therapy to Receive FDA Regenerative Medicine Advanced Therapy (RMAT) Designation
RMAT designation expected to expedite development; 72 weeks interim clinical trial data showing sustainable reduction of TTR over 90% with no significant adverse events. SUZHOU, China, May 29, 2025 /PRNewswire/ -- AccurEdit Therapeutics today announced that its internally developed in vivo gene ...
2025-05-29 20:00
1844
Neuronata-R® Stem Cell Therapy Shows Promise in ALS Phase 3 Subgroup Analysis, Moves Toward FDA Accelerated Approval
Meaningful efficacy observed in slow-progressor subgroup; NfL biomarker improvements support potential for accelerated regulatory pathway SEOUL, South Korea, May 29, 2025 /PRNewswire/ -- Neuronata-R®, an autologous bone marrow-derived mesenchymal stem cell (MSC) therapy for amyotrophic lateral s...
2025-05-29 20:00
2426
China's HER2-Targeted ADC Trastuzumab Rezetecan Gains NMPA Approval for HER2-Mutant NSCLC
SHANGHAI, May 29, 2025 /PRNewswire/ -- The National Medical Products Administration has recently granted approval for Trastuzumab rezetecan,China's first domestically developed antibody-drug conjugate (ADC), for treatment of adult patients with unresectable locally advanced or metastatic non-smal...
2025-05-29 17:27
1991
Kexing Biopharm's GB18 project received clearance of IND application from NMPA and FDA
SHENZHEN, China, May 28, 2025 /PRNewswire/ -- On May 26th, Kexing Biopharm (688136.SH) announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for its independently developed innovative product, GB18. Moreover, GB18 has previo...
2025-05-29 11:47
2263
Lunit Launches Enhanced Lunit INSIGHT CXR4, Secures CE MDR Certification for Expanded AI Capabilities
Next-generation AI solution introduces new clinical features and broader disease detection for chest X-rays SEOUL, South Korea, May 28, 2025 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI for cancer diagnostics and therapeutics, today announced the official launch and CE certifi...
2025-05-28 21:00
2649
IonOpticks Generation 4 Aurora Series® sets a new benchmark in chromatography
MELBOURNE, Australia, May 28, 2025 /PRNewswire/ -- IonOpticks
2025-05-28 20:00
1596
Formosa Pharmaceuticals and Adalvo Limited Announce Licensing Agreement for Clobetasol Propionate Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain
TAIPEI, May 28, 2025 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TW) announced that the company has entered into an exclusive licensing agreement with Adalvo Limited ("Adalvo") in the European and Brazilian markets for exclusive rights to the commercialization of clobeta...
2025-05-28 20:00
3256
CARsgen's Satri-cel Granted Priority Review by the NMPA
SHANGHAI, May 28, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the Center for Drug Evaluation (CDE) ofChina's National Medical Products Administration (NMPA) has granted Priority R...
2025-05-28 12:10
2129
Terumo Interventional Systems Announces Commercial Availability of Its ROADSAVER™ Carotid Stent System
– Innovative, dual-layer micromesh, closed-cell stent with the flexibility of an open-cell stent for maximizing clinical outcomes in carotid artery stenting procedures – SOMERSET, N.J., May 27, 2025 /PRNewswire/ -- Terumo Interventional Systems (TIS), a division of Terumo Corporation, is please...
2025-05-28 01:40
2186
Alma Unveils Alma IQ at Eighth Global Alma Academy in Dubrovnik
The next-generation skin analysis platform, set to redefine the aesthetic
consultation experience
CAESAREA, Israel, May 27, 2025 /PRNewswire/ -- Alma
2025-05-27 13:00
2262
ZYLOX Unicorn™ Vascular Closure Device Receives Regulatory Approval in Indonesia
HANGZHOU, China, May 26, 2025 /PRNewswire/ -- Zylox-Tonbridge Medical Technology Co., Ltd. ("Zylox-Tonbridge" or the "Company") today announced that its proprietary ZYLOX Unicorn™ Vascular Closure Device (VCD) has received regulatory approval inIndonesia. This marks the ZYLOX Unicorn™ Vascular Cl...
2025-05-27 10:14
3115
SeekInCare: New Multi-Omics Blood Test Shows Promise for Early Cancer Detection Across Multiple Cancer Types
SAN DIEGO, May 26, 2025 /PRNewswire/ -- A groundbreaking study published in the Journal of Molecular Diagnostics reports the successful clinical validation of SeekInCare®, a novel, non-invasive multi-omics blood test designed for the early detection of multiple cancer types. Developed by research...
2025-05-26 23:00
2475
Lunit Highlights AI's Role in Advancing Precision Oncology at ASCO 2025 with 12 Studies
SEOUL, South Korea, May 26, 2025 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI for cancer diagnostics and therapeutics, today announced that 12 studies featuring its AI-powered digital pathology solution will be presented at the 2025 American Society of Clinical Oncology (ASCO) ...
2025-05-26 21:00
2312
MGI Tech Showcases Comprehensive Multi-Omics Solutions at ESHG 2025 Milan
MILAN, May 26, 2025 /PRNewswire/ -- MGI Tech Co., Ltd. (MGI), a company dedicated to developing core tools and technologies that drive innovation in life sciences, unveiled cutting-edge multi-omics technologies at the European Society of Human Genetics (ESHG) 2025 conference inMilan. At Booth #31...
2025-05-26 18:30
1910
Dizal to Highlight its Portfolio Advances in Hematologic Malignancies and Lung Cancer at ASCO 2025
* DZD8586 demonstrated significant anti-tumor efficacy in heavily pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients with ORR of 84.2% * DZD6008, a BBB-penetrant 4th generation EGFR TKI, showed encouraging and durable anti-tumor activity with favorable safet...
2025-05-26 18:06
2294
VUNO Showcases DeepCARS® at AACN NTI 2025, Highlighting AI-Driven Cardiac Arrest Risk Prediction
– Company engages U.S. critical care professionals with data-driven early warning solution MARLBOROUGH, Mass., May 26, 2025 /PRNewswire/ -- VUNO, a global medical AI company, presented its flagship solution VUNO Med®–DeepCARS® at the 2025 National Teaching Institute & Critical Care Exposition (N...
2025-05-26 13:50
2293
World's First -- XellSmart's Allogeneic iPSC-derived Regenerative Cell Therapy for Spinal Cord Injury Officially Approved by the U.S. FDA for a Registrational Phase I Clinical Trial
SUZHOU, China, May 25, 2025 /PRNewswire/ -- In May 2025, XellSmart Biopharmaceutical (Suzhou/Shanghai) Co., Ltd. officially announced that XellSmart-developed off-the-shelf allogeneic iPSC-derived subtype-specific neural regenerative cell therapy has received official approval from bothChina's N...
2025-05-26 09:00
2349
Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths
* YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar[1] * Celltrion previously received interchangeability (IC) designation for YUFLYMA® (adalimumab-aaty) in prefilled syringes (20mg & 80mg); Expanded interchangeabilit...
2025-05-24 01:47
4403
/DISREGARD RELEASE: Celltrion/
We are advised by Celltrion that journalists and other readers should disregard the news release, Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths, issued21-May-2025 over PR Newswire. ...
2025-05-24 00:01
4393
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