Pharmaceuticals

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 1832

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 1402

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 2392

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 1039

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 1355

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 2360

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 2268

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 1916

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 1259

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 1829

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 2025

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 1515

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 2105

FDA Lifts Clinical Hold on NUZ-001

Highlights: * U.S. FDA lifts the Clinical Hold on NUZ‑001, Neurizon®'s lead investigational therapy for ALS * Clears the way for entry into the HEALEY ALS Platform Trial expected to commence in Q4 CY2025 * IND supported by robust preclinical safety data and comprehensive manufacturing and ...

2025-10-06 14:06 1798

MedHub-AI Announces National Reimbursement Approval in Japan for AutocathFFR™

TEL AVIV, Israel, Oct. 3, 2025 /PRNewswire/ -- MedHub-AI today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved national reimbursement for the company's AutocathFFR™ System, effectiveOctober 1, 2025. The decision follows regulato...

2025-10-03 07:00 1591

Celltrion launches AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation in the United States

* The AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation was approved in January 2025 by the FDA to treat the same conditions as the reference product ACTEMRA® (tocilizumab) * AVTOZMA is Celltrion's fifth immunology biologic and seventh biosimilar approved by the FDA * This launch stre...

2025-10-02 20:30 1883

MD Logistics Makes Largest Indiana Business Location Fully cGMP-compliant

- Total Area of 37,000m2, Enhanced Pharmaceutical Logistics Capacity - TOKYO, Oct. 1, 2025 /PRNewswire/ -- MD Logistics LLC (hereinafter "MD Logistics"), a group company of NIPPON EXPRESS HOLDINGS, INC., completed renovation of the South Area of its largest logistics base inPlainfield, in the U....

2025-10-01 15:00 1493

TAHO Pharma Announces Submission of New Drug Application (NDA) to the U.S. FDA for TAH3311 - The World's First Apixaban Oral Dissolving Film - Represents a Transformational Advancement in Anticoagulant Therapy

TAIPEI, Oct. 1, 2025 /PRNewswire/ -- TAHO Pharmaceuticals Ltd. ("TAHO Pharma") today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TAH3311, the world's first Apixaban Oral Dissolving Film (ODF). This submission marks a significant re...

2025-10-01 14:16 1519

Full-Life Technologies Announces US$77 Million Financing to Accelerate Development of its Radiopharmaceutical Pipeline and Manufacturing Capabilities

* Series C led by Junson Capital along with new investor syndicate and existing shareholders * Funding will further advance Full-Life's global radiopharmaceutical pipeline and manufacturing capabilities inBelgium * Additional debt financing provides an alternative financing solution for Ful...

2025-09-30 08:00 1610

Hanmi's Oral Delivery Platform Compound Licensed to Gilead

Hanmi and HHP will grant Gilead an exclusive license to Encequidar and provide access to drug supply. SEOUL, South Korea, Sept. 29, 2025 /PRNewswire/ -- Hanmi Pharm announced on September 29 that it has entered into a global licensing and collaboration agreement with Gilead Sciences, Inc. ("Gile...

2025-09-29 17:45 1317
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