AllSci News
FDA sets out potency testing approach for personalized cancer vaccines
Category: Regulatory Policy | Regulatory Body: FDA/CBER | Geography: United States | Policy Instrument: Guidance document | Topics: Potency assay...
FDA consolidates cell and gene therapy development guidance
Category: Regulatory Policy | Regulatory Body: FDA/CBER | Geography: United States | Policy Instrument: Guidance document
AI antibody design struggles to beat simple baselines in 29-organization benchmark
A prospective, blinded competition involving 29 organizations and 511 AI-designed antibody sequences has produced the most rigorous public assessment to...
Kiora completes global licensing map for KIO-301 with South Korea deal to Chong Kun Dang
Kiora Pharmaceuticals (Nasdaq: KPRX) has licensed South Korean development and commercialization rights for KIO-301, its molecular photoswitch for retinitis...
FDA approves Regeneron’s Pasatru as second therapy for rare bone disease FOP
The US FDA has approved Pasatru (garetosmab-grts), a fully human anti-Activin A monoclonal antibody developed by Regeneron Pharmaceuticals (Nasdaq: REGN),...
Teva's first-in-class Tourette drug filed for approval with FDA priority status
The US FDA has accepted Teva Pharmaceutical Industries' (NYSE: TEVA) New Drug Application for ecopipam (EBS-101), a selective dopamine D1 receptor...
Lilly expands vaccine push with Amplitude's next-generation RNA platform
Eli Lilly and Company (NYSE: LLY) has entered a research collaboration and licensing agreement with Boston-based Amplitude Therapeutics to discover and...
FDA approves Genglycos as first gene therapy for glycogen storage disease type Ia
The US FDA has granted accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr), an AAV8 gene therapy developed by Novato, California-based...
Oblenio exercises LBL-051 option, securing worldwide rights from Leads Biolabs
Oblenio Bio, the Cambridge, Massachusetts-based spinout formed by Aditum Bio around a trispecific T-cell engager (TCE) licensed from China-based Nanjing...
GenFleet tests dual RAS blockade, cachexia strategy in Phase II pancreatic cancer trial
GenFleet Therapeutics (Shanghai) Inc. (HKEX: 02595) has initiated a three-arm Phase II study testing two novel combination regimens against GFH375...
Leads Biolabs' PD-L1/4-1BB opamtistomig posts 77.4% ORR in 1st-line sqNSCLC
Phase II data for opamtistomig, Nanjing Leads Biolabs' (HKEX: 9887) PD-L1/4-1BB bispecific antibody, in first-line non-small cell lung cancer (NSCLC) have...
Onco-Innovations secures option on LAG-3 small-molecule program from Ifowonco
Calgary-based Onco-Innovations Limited (CBOE CA: ONCO / OTCQB: ONNVF) has signed a non-binding letter of intent with Ifowonco Informatics Incorporated to...
Edesa Biotech raises USD 25m to fuel vitiligo Phase II
Canada-based Edesa Biotech, Inc. (Nasdaq: EDSA) announced the pricing of a USD 25 million underwritten public offering on August 19, 2026, with proceeds...
Akiram secures lutetium-177 supply deal for CD44v6 radiopharmaceutical
Sweden-based Akiram Therapeutics has secured a supply agreement with Germany-based ITM Isotope Technologies Munich SE for non-carrier-added lutetium-177...
Network Bio raises USD 50m for patient tissue-trained AI platform
Palo Alto-based Network Bio has launched with USD 50 million in financing to build disease-specific AI models trained on multimodal patient tissue, blood,...
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