Medical/Pharmaceuticals

Mabwell's CDH17-targeting ADC 7MW4911 Receives IND Clearance from NMPA

SHANGHAI, Oct. 14, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its self-developed CDH17-targeting ADC (R&D code: 7MW4911) received IND clearance from the National Medical Products Administration (NMPA) inChina to ini...

2025-10-14 20:00 919

Clover Announces Positive Phase I Clinical Data for RSV-hMPV-PIV3 Combination Vaccines and for RSV Re-Vaccination in Older Adults

-- Results indicate potential best-in-class RSV+hMPV±PIV3 combination vaccines, with the potential ability to re-vaccinate individuals previously receiving approved RSV vaccines to restore and broaden protection-- -- Increases in neutralizing antibodies of approximately 6-8 fold for RSV, 6-9 fol...

2025-10-14 18:18 1001

Natural Field Drives Breakthroughs in Co-loading Liposome Technology, Accelerating Upgrading of Raw Materials for Cardiovascular and Gut Health

XIAN, China, Oct. 13, 2025 /PRNewswire/ -- Natural Field has achieved new continuous research breakthroughs in co-loading liposome technology, with remarkable progress particularly in the development of co-loading Coenzyme Q10 (CoQ10) liposome and co-loading curcumin liposome raw materials. This ...

2025-10-13 23:00 1114

Visionary Holdings (Nasdaq: GV) Secures Global License for Breakthrough Stem Cell Technology Aimed at Diabetes Remission and Potential Complete Cure in a USD 150 Billion Global Market

TORONTO, Oct. 13, 2025 /PRNewswire/ -- Visionary Holdings Inc. ("GV" or the "Company"), a technology-driven multinational enterprise listed on Nasdaq (Nasdaq: GV), today announced that its wholly owned subsidiary,Visionary Holdings (Asia) Limited, has entered into a Global Product and Technology ...

2025-10-13 21:40 1508

iRegene Therapeutics announced promising NouvNeu001 Phase I clinical data

CHENGDU, China, Oct. 13, 2025 /PRNewswire/ -- iRegene Therapeutics Co., Ltd. ("iRegene" or the "Company") is recognized as a biotechnology company pioneering chemically induced allogeneic cell therapy. iRegene's lead product, NouvNeu001, is the 1st iPSC therapy to receive IND approval from both t...

2025-10-13 21:00 928

NEXTBIOMEDICAL Announces First Patient Enrolled in U.S. FDA Pivotal Trial of Nexsphere-F™ for Knee Osteoarthritis Pain

* RESORB Study Marks Major Step Toward U.S. Regulatory Approval and Global Commercialization SEOUL, South Korea, Oct. 13, 2025 /PRNewswire/ -- NEXTBIOMEDICAL CO., LTD. (KOSDAQ: 389650), an innovative medical device company based inSouth Korea, today announced the enrollment of the first patient...

2025-10-13 21:00 1044

Complete Genomics announces Gene by Gene as its newest sequencing service provider at ASHG

BOSTON, Oct. 13, 2025 /PRNewswire/ -- Complete Genomics , a leading innovator in genomic sequencing, today announced at the American Society of Human Genetics Annual Meeting that it has addedHouston-based Gene by Gene,  a leading ge...

2025-10-13 21:00 1043

Thousand Oaks Biologics Shanghai ADC Site receives EU QP Declaration

SHANGHAI, Oct. 13, 2025 /PRNewswire/ -- Thousand Oaks Biologics' antibody-drug conjugate (ADC) manufacturing site successfully passed an audit conducted by a European Union Qualified Person (QP) and formally received a QP Declaration. This milestone certifies that the company's quality management...

2025-10-13 20:00 859

ReviR Therapeutics Receives Orphan Drug Designation from FDA for RTX-117 to Treat Charcot-Marie-Tooth Disease

BRISBANE, Calif. , Oct. 13, 2025 /PRNewswire/ -- ReviR Therapeutics, a biotech company focused on developing novel treatments for neurogenetic diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for RTX-117, its lead investigational...

2025-10-13 18:00 924

GC Biopharma Secures CMO Rights for Shingles Vaccine from Curevo Vaccine

YONGIN, South Korea, Oct. 13, 2025 /PRNewswire/ -- GC Biopharma (006280.KS), a South Korean biopharmaceutical company, announced today that it has signed an agreement with Curevo Vaccine to secure contract manufacturing (CMO) rights for amezosvatein (development name: CRV-101), a recombinant shin...

2025-10-13 12:38 1043

Smartee Launches World's First Sleep Aligner Combining Anti-Snoring Therapy with Teeth Alignment

SHANGHAI, Oct. 11, 2025 /PRNewswire/ -- Smartee Denti-Technology today announced the global launch of theSmartee Sleep Aligners, a clear aligner device designed to help manage obstructive sleep apnoea hypopnoea syndrome (OSAHS) and primary snoring (PS). The new series includes two versions: Smart...

2025-10-13 09:38 950

Ascletis Selects a Best-In-Class Once-Monthly Subcutaneously Administered GLP-1R/GIPR Dual Peptide Agonist, ASC35, for Clinical Development

- In head-to-head non-human primate (NHP) studies, average observed half-life of ASC35 was approximately 14 days, 6-fold longer than tirzepatide, which supports once-monthly subcutaneous (SQ) dosing in humans. - In head-to-head NHP studies, drug exposures of ASC35 intravenous (I.V.) and SQ admin...

2025-10-13 08:10 1204

C-Ray Therapeutics (Chengdu) Co., Ltd Congratulates Partner Biokin Pharmaceutical on NMPA IND Approval of First Proprietary ARC Drug [177Lu]-BL-ARC001

CHENGDU, China, Oct. 11, 2025 /PRNewswire/ -- C-Ray Therapeutics (Chengdu) Co.,Ltd proudly congratulates its strategic partner,Biokin Pharmaceutical, on receiving implied approval from theNational Medical Products Administration (NMPA) for the clinical trial application of [177Lu]-BL-ARC001 Injec...

2025-10-11 20:45 2222

Renalys Announces Completion of Primary Endpoint Data Collection for Phase III Clinical Trial of Sparsentan for Iga Nephropathy in Japan

TOKYO, Oct. 10, 2025 /PRNewswire/ -- Renalys Pharma, Inc. (Headquarters: Chuo-ku,Tokyo; "Renalys") announced today that it has completed data collection for the primary endpoint in the Phase III clinical trial of sparsentan (development code: RE-021) for IgA nephropathy inJapan. The primary endp...

2025-10-10 14:00 917

WuXi Biologics Receives MSCI AAA ESG Rating for Third Consecutive Year

SHANGHAI, Oct. 9, 2025 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), announced it has received the esteemed AAA ESG rating from Morgan Stanley Capital International (MSCI) for the third consecutive year. This to...

2025-10-10 08:30 1111

Celltrion receives U.S. FDA approval for EYDENZELT® (aflibercept-boav), biosimilar referencing EYLEA® (aflibercept)

* EYDENZELT® is approved for the treatment of patients with neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR) * Celltrion plans to enter the U.S. ophthalmology market to m...

2025-10-10 06:56 1381

POMDOCTOR LIMITED Announces Closing of Initial Public Offering

GUANGZHOU, China, Oct. 9, 2025 /PRNewswire/ -- POMDOCTOR LIMITED (Nasdaq: POM) (the "Company" or "POMDOCTOR"), a leading online medical services platform for chronic diseases inChina, today announced the closing of its initial public offering (the "Offering") of 5,000,004 American Depositary Shar...

2025-10-10 04:05 1892

Samsung Biologics Introduces Optimized Manufacturing Framework, ExellenS™

* ExellenS TM applies optimized facility designs, equipment, and processes across all sites to ensure equivalency and speed * ExellenS TM combines the company's commitment to operational excellence with its core manufacturing competencies, guided by standardization, simplification, and scalab...

2025-10-09 19:00 1178

Advantech AOM-5721 Combines SMARC Design and Qualcomm Dragonwing™ QCS6490 for Next-Gen Edge AI

TAIPEI, Oct. 9, 2025 /PRNewswire/ -- Advantech (TWSE: 2395), a global leader in edge computing and AI solutions, is proud to announce the launch of the AOM-5721, a SMARC-based Arm Computer-on-Module powered by the Qualcomm® Dragonwing™ QCS6490 SoC. By combining Advantech's expertise in compact, ...

2025-10-09 17:05 1051

EDAN Expands U.S. Operations with New Manufacturing Hub

Facility marks EDAN's 30th anniversary and kickstarts global supply chain ecosystem SAN DIEGO, Oct. 8, 2025 /PRNewswire/ -- Edan Instruments, Inc. (300206.SZ), a global leader in medical device innovation, announced the official opening of its new U.S. manufactu...

2025-10-09 06:53 1002
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