Pharmaceuticals

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 08:43 920

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 1967

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 1361

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 22:00 810

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 15:00 718

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 14:42 705

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 13:00 883

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 08:00 735

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 19:00 846

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 18:46 893

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 16:00 820

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 15:26 828

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 1158

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 1020

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 1091

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 12:32 975

Strategic Partnership | Sanyou Bio and Korea's FatiAbGen Join Forces to Expand the Global Biopharma Market

SHANGHAI, Nov. 27, 2025 /PRNewswire/ -- Sanyou Biopharmaceuticals (Shanghai) Co., Ltd. ("Sanyou Bio") andSouth Korea's FatiAbGen Co., Ltd. today jointly announced the signing of a comprehensive strategic collaboration agreement covering joint project development, exclusive representation in the K...

2025-11-27 22:00 1122

Once-Monthly GLP-1 RA | Gan & Lee Pharmaceuticals Initiates Phase 3 Clinical Study (GRADUAL-3) of the First Chinese Once-Monthly GLP-1 RA for Weight Management

BEIJING, Nov. 27, 2025 /PRNewswire/ -- Gan & Lee Pharmaceuticals (Gan & Lee, stock code: 603087.SH) announced the initiation of GRADUAL-3, its third large-scale phase 3 clinical study of the glucagon-like peptide-1 receptor agonist (GLP-1 RA) bofanglutide (research code: GZR18) injection in adult...

2025-11-27 16:57 906

IASO Bio Announces BLA Approval of Fucaso (Equecabtagene Autoleucel) by the Hong Kong Department of Health for the Treatment of Relapsed or Refractory Multiple Myeloma

SHANGHAI and NANJING, China and PLEASANTON, Calif., Nov. 27, 2025 /PRNewswire/ -- IASO Biotechnology ("IASO Bio"), a commercial-stage biopharmaceutical company dedicated to the discovery, development, manufacturing, and commercialization of novel cell therapies and biologics for hematologic mali...

2025-11-27 13:44 876

SK Biopharmaceuticals Expands Radiopharmaceutical Therapy Portfolio with Second In-licensed Candidate from Wisconsin Alumni Research Foundation

New addition strengthens SK Biopharmaceuticals' radiopharmaceutical therapy portfolio and reinforces its R&D capabilities through global partnerships and value chain integration SEOUL, South Korea, Nov. 26, 2025 /PRNewswire/ -- SK Biopharmaceuticals, CO., Ltd., a biotech company specializing in ...

2025-11-27 10:39 981
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