Pharmaceuticals
Serina Therapeutics announced FDA clearance of its IND application for SER-252, an innovative apomorphine therapy for advanced Parkinson's disease, marking a significant regulatory victory after successfully addressing previous clinical hold concerns.
Biotechnology
Siren Biotechnology announces FDA clearance for SRN-101, marking the first FDA-cleared AAV-based therapy specifically designed for oncology, advancing into human clinical trials for high-grade glioma treatment.
Biotechnology
Intellia Therapeutics announces FDA lift of clinical hold on MAGNITUDE-2 Phase 3 trial for its CRISPR-based therapy targeting hereditary transthyretin amyloidosis, marking a crucial milestone in navigating safety concerns in gene editing.
Biotechnology
UK-based Scancell Holdings announced FDA clearance for its Phase 3 trial of iSCIB1+, a novel DNA immunotherapy for advanced melanoma, following compelling Phase 2 data showing a 24-percentage-point improvement in progression-free survival.
Pharmaceuticals
COVID-19 vaccines did more than help end a global pandemic. They also introduced the public to a once-fringe idea: RNA itself can be medicine. Silexion Therapeutics is using RNAi to advance a next generation potential therapy for once of the toughest cancers | NASDAQ: SLXN
Biotechnology
The FDA's acceptance of Tasly's 3P Characterization of MSCs Assay marks the first FDA-recognized quality control standard for mesenchymal stromal cells, establishing a new benchmark for the cell therapy industry and accelerating the path to consistent, safe, and effective MSC-based therapies.
Biotechnology
Wugen's soficabtagene geleucel receives FDA Breakthrough Therapy Designation as the first allogeneic CAR-T therapy for T-cell leukemia, marking a transformative milestone in cell therapy innovation.
Nasus Pharma (NYSE: NSRX) announced compelling interim Phase 2 results this week for NS002, its investigational intranasal epinephrine powder, demonstrating pharmacokinetic advantages over the standard-of-care EpiPen autoinjector. The data showed NS002 achieved both faster absorption and higher peak concentrations of epinephrine—critical factors in a medical emergency where every minute
Biotechnology
Hyundai Bioscience announces Phase 2 FDA trials for XAFTY, a revolutionary broad-spectrum antiviral targeting multiple viral threats including dengue, influenza, COVID-19, and RSV.
Pharmaceuticals
Eli Lilly announced FDA Breakthrough Therapy Designation for sofetabart mipitecan (LY4170156), a novel folate receptor alpha-targeted ADC for platinum-resistant ovarian cancer, offering hope to patients with limited treatment options.
Biotechnology
In a significant regulatory milestone that underscores the growing momentum in precision oncology, Shanghai-based D3 Bio announced today that the U.S. Food and Drug Administration has cleared two Investigational New Drug (IND) applications, enabling the company to advance its next-generation KRAS-targeted therapies into critical clinical trials. The dual clearance
Biotechnology
Antengene Corporation presented compelling clinical data at the J.P. Morgan Healthcare Conference, showcasing robust efficacy results for its lead antibody-drug conjugate (ADC) and unveiling an ambitious pipeline of next-generation cancer treatments.