Medical/Pharmaceuticals
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
951
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
1011
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
1226
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
1101
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
1311
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
2320
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
981
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
1304
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
1770
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
2037
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
1423
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
1224
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.
2025-10-09 06:53
1150
C-Ray Therapeutics (Shanghai) Co., Ltd. Presents Breakthrough Clinical Data of Novel Targeted Alpha Therapy 225Ac-PSMA-CY313 at EANM 2025
BARCELONA, Spain, Oct. 8, 2025 /PRNewswire/ -- During the 2025 Annual Congress of the European Association of Nuclear Medicine (EANM 2025), C-Ray Therapeutics (Shanghai) Co., Ltd. ("C-Ray Shanghai"), a company dedicated to the development of innovative targeted radiopharmaceuticals, announced pro...
2025-10-08 22:20
1166
Alpha Fusion and Kobe City Medical Center General Hospital Establish At-211 Investigational Drug Supply System
〜Driving Technology Transfer and Test Manufacturing Following Regulatory Approval to Launch Company-Led af-001 Trial〜 TOKYO, Oct. 8, 2025 /PRNewswire/ -- Alpha Fusion Inc. (Alpha Fusion) is proud to announce a joint initiative with the Kobe City Medical Center General Hospital (KCGH) to establis...
2025-10-08 21:00
1205
POMDOCTOR LIMITED Announces Pricing of Initial Public Offering
GUANGZHOU, China, Oct. 8, 2025 /PRNewswire/ -- POMDOCTOR LIMITED (the "Company" or "POMDOCTOR"), a leading online medical services platform for chronic diseases inChina, today announced the pricing of its initial public offering (the "Offering") of 5,000,004 American Depositary Shares ("ADSs") at...
2025-10-08 20:00
1629
Hope Medicine Inc. Announces Successful Completion of a Global Phase 2 Study of a Potential First-in-Class Endometriosis Treatment
HMI-115 demonstrated statistically significant improvement in endometriosis pain The mean dysmenorrhea pain score was reduced by 42% The mean non-menstrual pelvic pain score was reduced by 52% Most of the patients had normal menstrual periods No typical peri-menopausal symptoms were reported Th...
2025-10-08 09:08
1883
CARsgen Presents Results on GPRC5D CAR-T CT071 in The Lancet Haematology
SHANGHAI, Oct. 7, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the results of CT071 (an autologous CAR T-cell product targeting GPRC5D) for the treatment of relapsed/refractory mul...
2025-10-08 08:15
1414
Celaid Therapeutics Raises JPY 1.055 Billion (USD 7.2 Million) in the First Close of its Series B Financing
TOKYO, Oct. 7, 2025 /PRNewswire/ -- Celaid Therapeutics Inc. ("Celaid"), today announced the successful completion of the 1st Close of its Series B financing round, raisingJPY 1.055 billion (USD 7.2 million) from venture capital firms and the Japan Agency for Medical Research and Development (AME...
2025-10-07 21:00
1508
Kazia Therapeutics Announces Collaboration and In-Licensing Agreement for First-in-Class PD-L1 Protein Degrader Program
SYDNEY, Oct. 7, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, today announced an exclusive collaboration and in-licensing agreement (the "Agreement") with QIMR Berghofer for a first-in-class PD-L1 degrader program. The lead optimized...
2025-10-07 20:30
2032
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