Seger Surgical Solutions Ltd., an Israel-based developer of minimally invasive surgical technologies, reported the successful completion of three first-in-human procedures using its SEGER IDEA laparoscopic bowel closure device during a clinical trial conducted at Zacamil Hospital in El Salvador. The procedures mark the first clinical use of the company’s device designed to perform bowel closure […]
Johnson & Johnson (J&J) has presented new pooled data from Phase 3 clinical trials showing that CAPLYTA (lumateperone), used as an adjunctive therapy with antidepressants, significantly improved remission rates in adults with major depressive disorder compared to placebo. The results, highlighted at the 64th Annual Meeting of the American College of Neuropsychopharmacology, indicate nearly double […]
Eli Lilly and Company has received Breakthrough Therapy designation from the U.S. Food and Drug Administration for its investigational antibody-drug conjugate, sofetabart mipitecan, also known as LY4170156. The designation applies to adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received prior treatment with bevacizumab and mirvetuximab soravtansine. The novel […]
Atossa Therapeutics Inc. has received Orphan Drug Designation from the U.S. Food and Drug Administration for its investigational compound (Z)-Endoxifen in the treatment of Duchenne muscular dystrophy (DMD). The designation, disclosed on January 16, 2026, supplements the previously granted Rare Pediatric Disease Designation for the same compound and indication. The move marks a notable regulatory […]
Illumina, Inc. has launched the Billion Cell Atlas, a large-scale genetic perturbation dataset designed to serve as foundational infrastructure for artificial intelligence-enabled drug discovery. Announced alongside strategic collaborations with AstraZeneca, Merck, and Eli Lilly and Company, the platform leverages CRISPR-based genome editing and single-cell RNA sequencing across more than 200 disease-relevant cell lines. This marks […]
Johnson & Johnson (J&J) has reported updated results from its Phase 1b/2 OrigAMI-1 trial evaluating amivantamab-vmjw in combination with chemotherapy for patients with RAS/BRAF wild-type metastatic colorectal cancer. The bispecific antibody, which targets epidermal growth factor receptor (EGFR) and MET, achieved confirmed response rates of 73 percent in the first-line setting and 44 percent in […]
GenSight Biologics S.A.’s early access rollout of GS010/LUMEVOQ in France and Israel has drawn new attention to how regulators are quietly repurposing compassionate use frameworks into strategic regulatory sandboxes for advanced therapies. As rare disease gene therapies edge closer to commercial viability, a patchwork of early access programs across key jurisdictions is beginning to influence […]
HUTCHMED (China) Limited announced on December 29, 2025, that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for fanregratinib (HMPL-453) with priority review for second-line treatment of adult patients with intrahepatic cholangiocarcinoma harboring FGFR2 fusion or rearrangement. The NDA submission is based on a Phase II registration study in China […]
Curasight A/S has dosed the first patient in a Phase 1 clinical trial of uTREAT for glioblastoma, launching the therapeutic half of its uPAR-targeting theranostic platform alongside its companion diagnostic, uTRACE, which is already in Phase 2 for prostate cancer. How curative ambitions shift when a theranostic platform enters human testing in glioblastoma Curasight’s advancement […]
GenSight Biologics S.A. has received approval from Israel’s Ministry of Health to provide early access treatment with its investigational gene therapy GS010/LUMEVOQ (lenadogene nolparvovec) for individual patients diagnosed with ND4-related Leber Hereditary Optic Neuropathy (LHON). This authorization permits bilateral intravitreal injections under compassionate use protocols, with treatments expected to begin in the first quarter of […]