INmune Bio Publishes Phase 2 MINDFuL Trial Results, Advances XPro Platform in Dementia
INmune Bio published phase 2 MINDFuL trial results in NPJ Dementia, highlighting XPro’s safety, biomarker engagement, and clinical efficacy in patients with mild Alzheimer’s Disease (AD).
Piramal Pharma Closes US FDA Inspection at Telangana Manufacturing Facility
Piramal Pharma has announced the successful closure of a US FDA inspection at its manufacturing facility in Digwal, Telangana, after receiving the Establishment Inspection Report (EIR) from the regulator, confirming the completion of the inspection process.
US FDA Approves Enhertu for New Early Breast Cancer Indications
Enhertu receives new US approvals for use before and after surgery in HER2-positive breast cancer, supported by positive DESTINY-Breast11 and DESTINY-Breast05 phase 3 trial results.
Glenmark Pharmaceuticals Launches Vancomycin for Injection USP in US
Glenmark Pharmaceuticals launches Vancomycin Hydrochloride for Injection USP in the US market, expanding its injectable portfolio in a segment valued at nearly USD 37.9 million annually.
OrganaBio Acquires Excellos Assets to Establish Bicoastal Cell Therapy Manufacturing Platform
The acquisition expands cGMP manufacturing, PBMC isolation and cryopreservation capabilities across the US to support cell therapy developers from preclinical to commercial stages.
SN BioScience Doses First Patient in Phase 1b/2 Clinical Trial of SNB-101
SN BioScience initiates first patient dosing in a global phase 1b/2 trial of SNB-101, a nanoparticle anticancer therapy for Small Cell Lung Cancer (SCLC).
FDA Clears IND Application for Chengdu Origen's Gene Therapy Targeting Hypertrophic Cardiomyopathy
Chengdu Origen Biotechnology and Vanotech have received US FDA clearance to begin clinical evaluation of KHN921, a potential first-in-class gene therapy designed to address the genetic root cause of hypertrophic cardiomyopathy linked to MYBPC3 mutations.
FDA Grants Accelerated Approval to BeOne Medicines' Beqalzi for Relapsed Mantle Cell Lymphoma
BeOne Medicines has secured accelerated US FDA approval for Beqalzi (sonrotoclax) to treat relapsed or refractory mantle cell lymphoma, marking an advancement in targeted therapies for patients with limited treatment options.
Dyno Therapeutics Unveils Next-Generation AI-Engineered AAV Capsids for CNS and Muscle Gene Delivery
Dyno Therapeutics introduced new AAV gene delivery capsids for central nervous system and muscular applications, highlighting enhanced cross-species transduction, reduced liver targeting and scalable manufacturing potential for next-generation genetic medicines.
Researchers Discover First Human Antibody Panel Targeting Measles Virus
NIH-funded researchers identify the first suite of human antibodies targeting the measles virus, paving the way for new antibody-based treatments.
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