ArkBio’s New Drug Application for ADHD Therapeutic Azstarys Accepted and Granted Priority Review by China NMPA
SHANGHAI, June 16, 2025 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the National Medical Products Administration (NMPA) has officially accepted its New Drug Application (NDA) for Azstarys (serdexmethylphenidate/dexmethylphenidate extended-release capsules) and granted it Priority Review designation. The investigational therapeutic drug is indicated for the treatment of Attention-Deficit/Hyperactivity...
Ubie Announces Cumulative Total Funding of Over $125M as US Efforts Target Expansion into Generative AI and Provider Solutions
Ubie's growth has been accelerated by recent strategic investment and acceptance into Mayo Clinic Platform Accelerate program Ubie's US Symptom Checker platform has seen 85% organic growth and a total user base of 4 million, helping deliver partnerships across patient advocacy and life sciences NEW YORK, June 26, 2025...
Shanton Receives Fast Track Designation from US FDA for Refractory Gout Program
SAP-001 is Shanton's lead investigational compound with First- and Best-in-Class potential in uncontrolled gout SINGAPORE and PRINCETON, N.J., July 25, 2025 /PRNewswire/ -- Shanton Pharma, a clinical-stage biotech company developing a novel treatment for gout, today announced that FDA has designated its Investigational New Drug SAP-001 as a Fast Track product for...
Abbott receives regulatory approval for the first denosumab biosimilar in Thailand, expanding access to bone disease treatment
Abbott's denosumab biosimilar is the first approved in Thailand, making advanced therapy for osteoporosis and cancer-related bone loss more affordable for millions of Thais This approval builds on Abbott's biosimilar portfolio in Asia Pacific, following recent launches in Malaysia and India BANGKOK, Aug. 26, 2025 /PRNewswire/ -- Abbott (NYSE: ABT), the global healthcare leader, has received regulatory approval...
Senhwa Biosciences CX-5461 Secures NCI Support to Advance into MYC-Driven Lymphoma, Driving Cross-Cancer and Global Licensing Value
TAIPEI and SAN DIEGO, Sept. 5, 2025 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has granted IND clearance for its innovative drug candidate Pidnarulex(CX-5461) ina Phase 1b/2 clinical trial in patients with B-cell lymphoma subtypes that harbors...
Kelun-Biotech’s New Drug Application for Its Novel Next-generation Selective RET Inhibitor A400/EP0031 Accepted for Review by the NMPA for the Treatment of RET-fusion positive NSCLC
CHENGDU, China, Sept. 23, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that a new drug application (NDA) for the Company's small molecule rearranged during transfection (RET) kinase inhibitor A400 (also known as EP0031) was accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of...
Mindray Unveils Project 2030 and Re-writes the Future of Women’s Health Ultrasound at ISUOG
CANCUN, Mexico, Sept. 23, 2025 /PRNewswire/ -- On September 15th, at ISUOG 2025 World Congress in Cancun, Mexico, Mindray unveiled Project 2030, an initiative to improve global access to ultrasound technology. The project was launched to an international audience of leading specialists, capping a conference that featured Mindray's OBG solutions as a key highlight. Mindray's Women Healthcare...
Lunit, CellCarta Announce Global Alliance to Expand Access to Digital Pathology AI for Clinical Trials
SEOUL, South Korea and MONTREAL, Sept. 24, 2025 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI for cancer diagnostics and biomarkers for oncology therapeutics, today announced a strategic partnership with CellCarta, a globally recognized provider of CRO laboratory services for pharmaceutical research and development. Under the partnership, Lunit's AI pathology solutions...
WuXi Biologics Launches WuXia™4.0, Targeted Integration Cell Line Platform TrueSite TI™，to Accelerate Biologics Development with High Titer and Superior Stability
TrueSite TI™, the fourth generation of WuXia™ cell line platform, leverages targeted integration technique to streamline clone screening and guarantees expression stability. The platform has achieved an average mAb titer exceeding 8.0 g/L with over 99% of clonal cell lines maintaining stable protein expression after passaging for 60 generations, which effectively mitigates the risk of titer drop during scale-up manufacturing to...
Smart Automation Meets Medical Innovation: ICP DAS & ICP DAS-BMP at Manufacturing World Tokyo 2025
HSINCHU, June 24, 2025 /PRNewswire/ -- ICP DAS and its biomedical business unit, ICP DAS-BMP, are pleased to announce their participation in Manufacturing World Tokyo 2025, one of Asia's premier industrial trade shows, held from July 9–11, 2025, at Makuhari Messe, Chiba, Japan. Image by ICP...
