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Opus Genetics Completes Patient Enrollment in Phase III Trial of Gene Therapy for Inherited Retinal Dystrophy
Precision Medicine Online USA Overview Opus Genetics has completed patient enrollment in its Phase III clinical trial for a gene therapy targeting severe inherited retinal dystrophy. This milestone signifies a critical step towards poten... -
Vertex’s CASGEVY Gene Therapy Expands FDA Approval to Pediatric Patients 2+ for Sickle Cell and Beta-Thalassemia; Umoja’s In Vivo CAR-T for Solid Tumors Enters Clinic
BioInsights USA Overview July 2026 marked significant progress in gene and cell therapy access, with Vertex Pharmaceuticals' CASGEVY receiving expanded FDA approval for pediatric patients aged 2 and older with sickle cell disease and tra... -
FDA Issues Warnings as No Approved Therapeutic Exosomes Exist in 2026 Amidst Reports of Adverse Events
OmniGenix USA Overview As of 2026, the U.S. FDA has not approved any therapeutic exosome products, issuing warnings against unauthorized sales due to reported adverse events. A 2025 review of clinical trials from 2014-2024 indicated favo... -
Replimune’s Tudriqev Secures FDA Accelerated Approval for Advanced Melanoma After Two Prior Rejections
BioPharma Dive USA Overview Replimune has achieved FDA accelerated approval for its advanced melanoma drug, Tudriqev, following two prior rejections and eventual support from an FDA advisory committee. The drug is approved for use in com... -
After Two Rejections, Replimune’s Melanoma Drug RP1 Secures Coveted FDA Accelerated Approval for Combination Therapy
Endpoints News USA Overview Replimune has successfully obtained FDA accelerated approval for its advanced melanoma drug, RP1 (marketed as Tudriqev), following a year-long dispute and two prior rejections. The approval, based on a Phase 2... -
DeepHealth AI Breast Ultrasound Tool Receives FDA 510(k) Clearance, Achieves 8% Sensitivity Increase and 37% Interpretation Time Reduction
MedTech Dive USA Overview DeepHealth has obtained U.S. FDA 510(k) clearance for its AI tool that automatically reads breast ultrasound images and generates diagnostic reports. Clinical trials demonstrated this breakthrough AI tool improv... -
Microquery Offers Instant Access to PubMed, FDA FAERS, and ClinicalTrials Datasets for AI Agents
Microquery Unknown Overview Microquery has announced instant access to a range of critical datasets for AI agents, including PubMed biomedical literature, FDA FAERS adverse event reports, arXiv preprints, and ClinicalTrials data. The pla... -
TFSF Ventures Unveils AI Agent Solution for Enhanced Pharma Pipeline Competitive Intelligence
TFSF Ventures Unknown Overview TFSF Ventures highlights the application of AI agents for competitive intelligence in the pharmaceutical sector, specifically for pipeline tracking. These AI agents integrate data from critical sources such... -
Cell & Gene Therapy Manufacturing Faces Deepening Bottlenecks: AmplifyBio, Exothera Close; Thermo Fisher Cuts Viral Vector Jobs, but FDA Eases Regulations to Support Growth
Endpoints News Global Overview Despite cell and gene therapies becoming a commercial reality, manufacturing remains the primary bottleneck. The CDMO sector is struggling with overcapacity and underfunding, leading to closures like Amplif... -
Catalent Bolsters End-to-End CDMO Services for Autologous & Allogeneic Cell Therapies, Including iPSC Center of Excellence
Catalent USA Overview Catalent is enhancing its end-to-end CDMO manufacturing support and process development services for both autologous and allogeneic cell therapies, covering CAR-T, TCR, TIL, NK cells, and iPSC- and MSC-derived treat...
