Sept. 17, 2026 -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that AK158D1, its investigational next-generation bispecific antibody-drug conjugate (ADC) targeting EGFR and TROP2, has secured Phase I clinical trial clearance from the Center for Drug Evaluation (CDE) under China's National Medical Products Administration (NMPA). The trial will assess the candidate in patients with advanced malignant solid tumors. AK158D1 is Akeso's fourth ADC to enter clinical development and joins

Sept. 16, 2026 -- Prescription-only treatment gives clinicians a new way to treat eligible adults with moderate to severe major depressive disorder at home, either as a standalone treatment or alongside medication Flow Neuroscience today announced that FL-100 is now available by prescription across the United States, introducing the first FDA-approved at-home transcranial direct current stimulation (tDCS) treatment for depression to the US market. FL-100 is intended for the treatment of modera

Cesalatamig is Currently Being Evaluated in Phase 1/2 Studies in the United States (NCT06635785) and in China (CTR20253261) Fast Track Designation Supports Expedited Development of Cesalatamig for Non-small Cell Lung Cancer (NSCLC) that Progressed after Concurrent or Sequential PD-(L)1-targeted Immunotherapy and Platinum-based Chemotherapy Sept. 16, 2026 -- OncoC4 Inc., a late clinical-stage biopharmaceutical company developing novel medicines for cancer and neurodegenerative diseases, today an

— IASO208 is the first China-originated lentiviral vector-based in vivo CAR-T therapy to receive FDA IND clearance — Supported by early clinical data from an investigator-initiated trial in China, IASO208 is expected to advance directly into a Phase 1b clinical study in the United States for relapsed/refractory B-cell non-Hodgkin lymphoma Sept. 16, 2026 -- IASO Biotechnology ("IASO Bio"), a commercial-stage biopharmaceutical company focused on the discovery, development, manufacturing, and comm

Trailblazing approach to leverage learnings from rare POLG disorders to inform development for Parkinson's and other age-related neurological diseases Sept. 15, 2026 -- Mighty Therapeutics (the "Company" or "Mighty"), a commercial-stage biotechnology company pioneering a new class of medicines that directly target mitochondrial dysfunction in rare and age-related diseases, is celebrating World Mitochondrial Disease Awareness Week by announcing today its initiation of a research collaboration wi

GSK has bet up to $750 million on a Chimagen Biosciences trispecific T-cell engager (TCE), positioning the Big Pharma to start phase 1 development of the multiple myeloma drug candidate next year. The deal comes two years after GSK paid China’s Chimagen $300 million upfront for a trispecific lupus prospect. Neither party has disclosed the targets of the new candidate, but GSK shed some light on the rationale for the trispecific design. TCEs have shown “transformational efficacy in multiple mye

Applying Multimodal AI Analytics to Inform Patient Selection and Therapeutic Strategy in BRCA1/2-Mutated Breast Cancers BostonGene, developer of the leading AI model for tumor and immune biology, today announced an expansion of its scientific collaboration with Dana-Farber Cancer Institute to deepen the understanding of the complex biological mechanisms driving BRCA1- and BRCA2-associated breast cancers. The collaboration applies BostonGene’s foundation model of tumor and immune biology and mul

NDA supported by positive results from the APEX pivotal trial demonstrating clinically meaningful responses and evidence of disease modification in patients with AdvSM PDUFA target action date set for June 29, 2027 Sept. 15, 2026 --- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for bezuclasti

Sept. 15, 2026 -- Xylo Bio, a clinical-stage biotechnology company developing novel neurotherapeutics for psychiatric and neurological disorders, today announced the first participants dosed in its Phase 1 clinical study of XYL-1001, a novel, selective 5-HT2A agonist being developed for major depressive disorder (MDD). The randomized, double-blind, placebo-controlled Phase 1 study is being conducted in Australia and is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmac

ENA Respiratory Begins Part B Dosing in INNA-051 Phase IIa Community Study Designed to Protect Against Symptomatic Viral Respiratory Infections Sept. 15, 2026 -- ENA Respiratory, a clinical-stage pharmaceutical company developing host defence enhancers for the prevention of complications associated with respiratory viral infections in at-risk populations, today announces it has dosed the first participants in Part B of its Phase IIa community study of INNA-051. INNA-051 is a virus-agnostic, o