Pharmaceuticals

INCLUSION OF TINENGOTINIB TABLETS IN THE LIST OF PRODUCTS FOR PRIORITY REVIEW BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION

NANJING, China and GAITHERSBURG, Md., Dec. 3, 2025 /PRNewswire/ -- TransThera Sciences Nanjing, Inc. (the "TransThera") announced that Tinengotinib tablets have been included in the List of Products for Priority Review by the Center for Drug Evaluation ("CDE") of the National Medical Products Adm...

2025-12-04 09:57 1347

High Response in Bladder Cancer: Immvira Announced Its MVR-T3011 Latest Clinical Results in BCG-Unresponsive Bladder Cancer Patients at 2025 Annual Meeting of the Society of Urologic Oncology

SUZHOU, China, Dec. 3, 2025 /PRNewswire/ -- On December 3, 2025 (local time in Arizona, USA), ImmVira Group ("ImmVira" or the "Company") announced a poster presentation at the 26th Annual Meeting of the Society of Urologic Oncology (SUO 2025). The presentation featured the latest interim clinical...

2025-12-04 08:00 2000

ImpriMed to Present Ex Vivo Drug Sensitivity Data in Acute Myeloid Leukemia in Oral Presentation at American Society of Hematology Annual Meeting

Studies Demonstrate xCellSense® Platform's Ability to Predict Clinical Response and Enable Patient Stratification for Drug Development. PALO ALTO, Calif., Dec. 3, 2025 /PRNewswire/ -- ImpriMed

2025-12-04 01:00 1615

Emerald Clinical Appoints Luke Gill as Vice President, Global Head of Oncology, Medical & Scientific Affairs

Accomplished biotech and CRO leader brings 25+ years of global oncology drug development and operational excellence to propel Emerald's continued growth. SINGAPORE, Dec. 3, 2025 /PRNewswire/ -- Emerald

2025-12-03 21:10 1865

Celltrion announces U.S. FDA approval of 300mg strength of OMLYCLO® (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to XOLAIR®

* FDA approval of OMLYCLO® (omalizumab-igec) 300 mg/2 mL solution in a single-dose prefilled syringe for subcutaneous injection expands dosing flexibility and supports tailored treatment for individual patients with certain allergic diseases * OMLYCLO® (omalizumab-igec) is the first and only ...

2025-12-03 08:43 3687

Kazia Therapeutics Announces Pricing of $50.0 Million Private Placement of Equity Securities

SYDNEY, Dec. 2, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, today announced that it has entered into a securities purchase agreement with certain established institutional and accredited investors for a private placement of equity ...

2025-12-02 22:00 4655

Nature Communications | Insilico Medicine Presents AI-empowered Dual-Action PROTAC Targeting PKMYT1

* AI Designs a Novel RPOTAC from Scratch: Insilico's generative AI platform, Chemistry42, successfully designed a first-in-class PROTAC targeting PKMYT1 by creating an entirely new inhibitor and its complex linker, demonstrating a powerful, end-to-end approach to new modality drug discovery. ...

2025-12-02 22:00 2915

Yuyu Pharma Announces Strategic Investment in Dalan Animal Health as Part of Accelerated Global Expansion in Animal Health

SEOUL, South Korea, Dec. 2, 2025 /PRNewswire/ -- Yuyu Pharma announced today that it has completed a strategic investment in Dalan Animal Health, a U.S.-based biotechnology company advancing an innate immunity–based platform for developing vaccines for honeybees and shrimp. The investment marks a...

2025-12-02 22:00 3362

Accord Healthcare Announces Launch of Denosumab∇ - Second Biosimilar in Bone Health

∇ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. LONDON, Dec. 2, 2025 /PRNewswire/ -- Accord Healthcare today announced the launch of Osvyrti (denosumab), a biosimilar to Prolia® (Amgen), and Jubereq (denosumab), a biosimilar to...

2025-12-02 15:00 1741

Amaran Biotech's Vaccine Adjuvant AB-801 Receives FDA Drug Master File (DMF) Filing Acknowledgement

HSINCHU, Dec. 2, 2025 /PRNewswire/ -- Amaran Biotech, a next-generation Contract Development and Manufacturing Organization (CDMO), announced that its self-developed, GMP-grade high-purity vaccine adjuvantAB-801 has received an Acknowledgement Letter from the U.S. Food and Drug Administration (FD...

2025-12-02 14:42 1303

GC Biopharma's Varicella Vaccine Strain 'MAV/06' Listed in WHO Position Paper

* Officially recognized by WHO as a standard varicella vaccine strain alongside Oka * Interchangeability endorsed, enhancing global supply security YONGIN, South Korea, Dec. 2, 2025 /PRNewswire/ -- GC Biopharma (006280.KS), a global biopharmaceutical company, today announced that its propriet...

2025-12-02 13:00 2446

Lynk Pharmaceuticals Announces FDA IND Approval of Its Allosteric TYK2 Inhibitor LNK01006

HANGZHOU, China and SHANGHAI and BOSTON, Dec. 2, 2025 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as "Lynk Pharmaceuticals"), a clinical-stage innovative drug development company focused on developing innovative therapies for immune and inflammatory diseases, today ann...

2025-12-02 08:00 5876

Generate:Biomedicines to Initiate Global Phase 3 Studies of GB-0895, a Long-Acting Anti-TSLP Antibody for Severe Asthma Engineered with AI

SOLAIRIA-1 and SOLAIRIA-2 will evaluate GB-0895 in approximately 1,600 patients with severe asthma whose disease remains inadequately controlled on current therapies These are the first global Phase 3 studies of a long-acting anti-TSLP antibody, marking a pivotal step as GB-0895 advances the pro...

2025-12-01 19:00 2127

Lee's Pharm Supports Disaster Relief Efforts for Wang Fuk Court in Tai Po

HONG KONG, Dec. 1, 2025 /PRNewswire/ -- Lee's Pharmaceutical Holdings Limited (" Lee's Pharm" or the "Group", stock code: 0950.HK) expresses its deep condolences to the victims of the serious fire at Wang Fuk Court inTai Po, which caused multiple casualties and left many residents homeless and in ...

2025-12-01 18:46 1514

Hedia appoints new CEO: Rasmus Kofoed to succeed Lars Christian Lund

COPENHAGEN, Denmark, Dec. 1, 2025 /PRNewswire/ -- Danish diabetes‑tech company Hedia is implementing a leadership change effective1 December 2025, when Rasmus Kofoed will take over as Chief Executive Officer (CEO). He succeeds Lars Christian Lund, who after approximately 2 years in the role has d...

2025-12-01 16:00 1670

The Wisdom Derived from the Great Migration: Hakka Medicine - The Unique "Medical Epic" of the Hakka People

HONG KONG, Dec. 1, 2025 /PRNewswire/ -- From November 23rd to 25th, the 7th World Hakka Conference was held in Meizhou,Guangdong. With the theme "Gathering Global Hakka Businesspeople to Foster High-Quality Development," the conference adhered to the principles of "openness, innovation, cooperati...

2025-12-01 15:26 2088

Ascletis Selects Its First Oral GLP-1R/GIPR/GCGR Triple Peptide Agonist, ASC37, for Clinical Development

-  Utilizing Ascletis' Peptide Oral Transport ENhancement Technology (POTENT), ASC37 oral tablets achieved average absolute oral bioavailability of 4.2%, approximately 9-, 30-, and 60-fold higher than semaglutide, tirzepatide, and retatrutide in the oral SNAC formulation, respectively, in head-to...

2025-11-30 18:15 2909

BioDlink Showcases Europe-China CMC Collaboration Amid Developmental Breakthrough

* Recognized as Biologics CDMO of the Year, BioDlink shares insights into the world's first approved EGFR-targeted ADC for recurrent/metastatic nasopharyngeal carcinoma * The company enables seamless Europe–China tech transfer and faster biologics development through an integrated, end-to-end...

2025-11-28 21:00 3240

Imugene and JW Therapeutics Announce a Collaboration to Advance onCARlytics and Carteyva® Combination in Solid Tumours

* Imugene and JW Therapeutics (Shanghai) Co., LTD have entered a strategic collaboration to evaluate a novel combination therapy using Imugene's onCARlytics (CF33-CD19) oncolytic virus and JW's CD19 CAR-T cell therapy, Carteyva®, in refractory solid tumors. * The collaboration includes precli...

2025-11-28 13:00 1850

The Annals of Oncology Publishes Results of Phase II Study of Sacituzumab Tirumotecan Monotherapy for Urothelial Carcinoma

CHENGDU, China, Nov. 28, 2025 /PRNewswire/ -- Recently, Clinical study results from Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", HKEX: 6990)'s TROP2 ADC sacituzumab tirumotecan (sac-TMT) monotherapy for advanced or metastatic urothelial carcinoma (UC) patients has been publ...

2025-11-28 12:32 3584
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