AllSci News
uniQure files AMT-130 BLA after stop-start FDA path
uniQure N.V. (Nasdaq: QURE) has submitted a Biologics License Application (BLA) to the US FDA seeking accelerated approval of ifezuntirgene inilparvovec...
Takeda taps Weave Bio for AI regulatory automation across 14 drug programs
San Francisco-based Weave Bio and Takeda have announced a collaboration to deploy Weave's AI-native regulatory automation platform across 14 of Takeda's...
Norroy advances first domestically developed PSMA-targeted therapy into pivotal China trial
China-based Norroy Bioscience Co., Ltd. has initiated a pivotal Phase III trial of 177Lu-NYM032, a prostate-specific membrane antigen (PSMA)-targeted...
Seoul team extends prime editing to large-scale DNA replacement
Researchers at Seoul National University College of Medicine have developed a prime editing-based system capable of replacing genomic sequences with DNA...
University of Toronto, SickKids develop chemically modified tRNA platform for cystic fibrosis nonsense mutations
A chemically modified, lipid nanoparticle-delivered suppressor transfer RNA platform has restored functional cystic fibrosis transmembrane conductance...
GSK advances dual-antigen mRNA flu vaccine to Phase III after positive Phase II
Positive Phase II data for GSK's mRNA seasonal influenza vaccine candidate FLUm3HA.b-3NA have cleared the bar for a Phase III efficacy trial, with the UK...
Teva's anti-IL-15 antibody cuts gluten-induced intestinal damage in Phase IIa celiac disease trial
A single subcutaneous dose of TEV-'408, Teva Pharmaceutical Industries' (NYSE: TEVA) investigational anti-interleukin-15 monoclonal antibody, significantly...
Raziel's RZL-012 meets Phase III endpoints for submental fat reduction, paving China NDA path
A pivotal 480-patient Phase III trial of utenpanium chloride (RZL-012) has met all primary and secondary efficacy and safety endpoints in submental fat (fat...
Vertex closes USD 10b Crinetics deal to establish endocrinology as fifth therapeutic pillar
Vertex Pharmaceuticals (Nasdaq: VRTX) completed its acquisition of Crinetics Pharmaceuticals on September 1, 2026, adding a commercially launched rare...
BigHat's AI-designed CDH17 antibody enters human testing for gastric cancer
San Mateo, California-based BigHat Biosciences has dosed its first patient with BHB810, a cadherin-17 (CDH17)-directed antibody-drug conjugate (ADC) for...
Ono Pharma taps Aitia's causal AI to identify neurological disease targets
Ono Pharmaceutical Co., Ltd. and Cambridge, Massachusetts-based Aitia, Inc. have announced a drug discovery partnership covering neurological diseases,...
Evotec and Plectonic combine T-cell platforms to tackle solid tumor selectivity challenge
Combining two preclinical platform technologies that each address a distinct failure mode of T-cell engager therapy in solid tumors, Evotec SE (Nasdaq: EVO)...
FDA grants breakthrough status to Juniper hypoxia tracer for radiation de-escalation in HPV-positive OPC
Bedminster, New Jersey-based Juniper Biosciences announced receipt of US FDA Breakthrough Therapy Designation (BTD) for JBS-003 (18F-fluoromisonidazole, or...
Ocugen launches Phase III trial of one-time gene therapy for geographic atrophy
Ocugen (Nasdaq: OCGN) has dosed the first patient in ArMaDa3, a global Phase III registrational trial of OCU410, an AAV5-based modifier gene therapy for...
Envudeucitinib misses Phase IIb lupus endpoints, subgroup signal keeps program alive
The Phase IIb LUMUS trial of envudeucitinib in systemic lupus erythematosus (SLE) failed to meet its primary and secondary endpoints in the overall patient...
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