Drug Discovery
Acepodia Secures FDA IND Clearance for ACE1831, Pioneering Gamma Delta T Cell Therapy in Autoimmune Disease
IND clearance paves the way for Acepodia to enter the clinic for the first time with its autoimmune program ACE1831 is an allogeneic gamma delta T...
November 18, 2024 | News
Ascentage Pharma’s Lisaftoclax NDA Accepted for Priority Review in China: A Potential First for Bcl-2 Inhibitors
Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unm...
November 18, 2024 | News
Mabwell's Nectin-4 Targeting ADC Secures IND Approval for Clinical Trials in Perioperative Urothelial Carcinoma and Advanced Solid Tumors
Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its novel Nectin-4 targeting ADC (R&D code: 9MW...
November 15, 2024 | News
SEKISUI Diagnostics Completes £15.7 Million cGMP Expansion for Enhanced Microbial Drug Substance Manufacturing in the UK
SEKISUI Diagnostics' microbial CDMO business announces it has completed construction of its £15.7 million ($20.7 million) cGMP capacity expansion&nbs...
November 15, 2024 | News
Taiwan's Caliway Biopharmaceuticals Receives EMA Orphan Drug Designation for CBL-514 in Dercum’s Disease Treatment
CBL-514 is the first and only drug to receive EMA Orphan Drug Designation for Dercum's disease treatment.- CBL-514 received both FDA Orphan Drug...
November 14, 2024 | News
Alphamab Oncology’s JSKN033 Receives Fast-Track Approval from Shanghai Drug Authority for Innovative Cancer Therapy Clinical Trials
Alphamab Oncology (stock code: 9966.HK) announced that a clinical trial (Study ID: JSKN033-102) of JSKN033, a high-concentration subcutaneous co-formulatio...
November 13, 2024 | News
Nordic Bioscience Secures FDA Letter of Support for CPa9-HNE Biomarker in Advancing IBD Clinical Trials
Nordic Bioscience, a leading biomarker company, announced that its CPa9-HNE biomarker assay received a Letter of Support (LoS) from the U.S. Food and Drug ...
November 12, 2024 | News
Australia’s Neurizon Therapeutics Secures Positive EMA Opinion for Orphan Medicinal Product Designation of NUZ-001 in ALS
Notice of positive opinion received from the European Medicines Agency for Orphan Medicinal Product Designation for NUZ-001 in Amyotrophic Lateral S...
November 12, 2024 | News
Harbour BioMed Files IND Application in China for Novel Antibody Therapy HBM9378/SKB378 Targeting COPD
Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel ant...
November 11, 2024 | News
Dizal Submits NDA to U.S. FDA for Sunvozertinib as a New Treatment Option for Advanced NSCLC with EGFR Exon 20 Insertion Mutations
Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announ...
November 11, 2024 | News
BioIVT and KRISHGEN BioSystems Forge Exclusive Agreement to Expand Access to High-Quality Biospecimen Solutions Across South Asia
-BioIVT, a global research partner and biospecimen solutions provider for drug and diagnostic development, announced an exclusive agreement* with KRI...
November 07, 2024 | News
China’s Leads Biolabs Secures FDA Orphan Drug Designation for LBL-034 in Multiple Myeloma Treatment
Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs") announced that LBL-034, a humanized bispecific T-cell engaging antibody target...
November 07, 2024 | News
Medidata Introduces Oncology and Vaccine Solutions to Streamline Phase II and III Trials with FDA-Aligned Patient-Centric Design
The new products combine Medidata's diverse technologies and experience from thousands of previous trials to streamline the management of Phase II an...
November 05, 2024 | News
Breast Cancer Drug Shows Promise for Treating Hereditary Hemorrhagic Telangiectasia, a Rare Vascular Disorder
A drug commonly used to treat breast cancer might be able to help people living with hereditary hemorrhagic telangiectasia (HHT) – a rare genetic ble...
November 05, 2024 | News
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