Pharmaceuticals
Hope Medicine Inc.'s HMI-115 Received U.S. FDA Fast Track Designation, Accelerating Global Development
HMI-115 received FDA Fast Track Designation based on results from a Phase II clinical trial for endometriosis Mean dysmenorrhea pain score reduced by 42% Mean non-menstrual chronic pelvic pain score reduced by 52% Most patients maintained normal menstrual cycles No typical peri-menopausal sympt...
2025-12-04 20:08
1975
Kelun-Biotech and Crescent Biopharma Announce Strategic Partnership to Develop and Commercialize Novel Oncology Therapeutics
Companies to advance CR-001, a PD-1 x VEGF bispecific antibody, and SKB105, an integrin beta-6-directed antibody-drug conjugate (ADC), in global markets and China Collaboration designed to accelerate and expand the development of synergistic combinations with CR-001 and ADCs, including SKB105 CR...
2025-12-04 19:50
1778
Menarini Asia-Pacific Expands Production Facilities, Strengthening Indonesia's Role as Regional Manufacturing Hub
* Menarini announces the expansion of MiLab facilities in Cikarang, including a new warehouse andenhanced production facility to meet growing export demands. * Another milestone includes the projected export of up to 700,000 units of Dermatix products toChina alone this year. * The event hig...
2025-12-04 14:30
1134
HiroPharmaConsulting (R) Granted Patent for AI-enabled Reliability Assurance Method for Pharmacovigilance Systems
OSAKA, Japan, Dec. 4, 2025 /PRNewswire/ -- HiroPharmaConsulting (R) Co., Ltd. announced that it has received a patent for an innovative Good Pharmacovigilance Practice (GVP) Computerized System Validation (CSV) methodology designed to ensure the reliability of pharmacovigilance systems equipped ...
2025-12-04 14:00
1141
Nona Biosciences Appoints Dr. Hongjiang Miao as Chief AI Officer to Advance A³ Strategy and AI-Driven Drug Discovery
CAMBRIDGE, Mass., Dec. 3, 2025 /PRNewswire/ -- Nona Biosciences ("Nona" or the "Company"), a global biotechnology company providing integrated solutions for biological drug discovery and development from I to I® (Idea to IND), today announced the appointment of Dr.Hongjiang Miao as Chief AI Offic...
2025-12-04 10:01
1494
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
869
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
953
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
1035
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
1350
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
1286
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
2151
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
1764
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
1242
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
915
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
846
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
1070
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
1057
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
1042
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
1015
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
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