Latest Biotech News

Eli Lilly agreed to acquire Orna Therapeutics in a deal worth up to $2.4 billion to secure an in‑vivo CAR‑T and circular RNA platform. Orna’s lead program, ORN‑252, is described as clinical‑trial...

The FDA issued a complete response letter rejecting Regenxbio’s RGX‑121 for Hunter syndrome, the company said. The regulator flagged concerns over the trial design, including the reliance on a...

Capsida Biotherapeutics reported that an autopsy confirmed cerebral edema as the cause of death in a patient treated in its suspended SYNRGY trial of CAP‑002 (AAV gene therapy for STXBP1). The...

Generate Biomedicines filed for an IPO days after dosing the first patient in Phase III with GB‑0895, an AI‑designed anti‑TSLP antibody for severe asthma. The company said proceeds will fund...

Takeda signed a multiyear discovery and R&D pact with Iambic to apply the biotech’s generative AI platform to small‑molecule programs across oncology, gastrointestinal and inflammation targets....

Two AI‑focused biotech financings closed this week as investors back algorithmic protein and immunology discovery. Seoul‑based Galux raised $29 million in a Series B to scale its AI‑driven...

Regulatory and legal pressure intensified after Hims & Hers announced a compounded oral semaglutide product. FDA commissioner Marty Makary publicly pledged swift action against mass‑marketed,...

The FDA approved a labeling update for axicabtagene ciloleucel (Yescarta), removing the prior contraindication for treating primary CNS lymphoma after data and regulatory review. The change...

Nektar Therapeutics reported one‑year maintenance data showing that monthly and quarterly dosing of rezpeg preserved stringent skin‑lesion improvements in 71% and 83% of patients with...

The British Journal of Cancer issued a formal retraction of a study examining Circular RNA 0000096 in gastric cancer after identifying issues that undermined the paper’s findings. The notice...

Eli Lilly has agreed to acquire Orna Therapeutics in a deal valuing the company at up to $2.4 billion, buying into Orna’s circular RNA platform and an in‑vivo CAR‑T candidate aimed at B...

The FDA issued a complete response rejecting Regenxbio’s RGX‑121 gene therapy for Hunter syndrome, citing concerns about patient‑population definition, use of a natural‑history control arm and...

Generate Biomedicines filed for an IPO days after dosing the first patient in Phase III for its lead AI‑designed antibody GB‑0895, targeting thymic stromal lymphopoietin (TSLP) in severe asthma....

Takeda signed a multiyear discovery and technology collaboration with Iambic Therapeutics to deploy Iambic’s generative AI tools across small‑molecule programs in oncology, GI and inflammation....

QuantX Biosciences closed an $85 million Series B led by Lilly and Sanofi Ventures to advance an immunology pipeline developed across China and the U.S. The round supports QuantX’s AI‑driven...

Medable launched an Agentic AI product designed to assist principal investigators in assessing electronic clinical outcome assessment (eCOA) data, automating reconciliation and highlighting items...

A study published in Nature Communications reports an association between receipt of the recombinant zoster vaccine (RZV) and reduced risk of developing dementia. Researchers analyzed population...

Researchers at Washington University School of Medicine and the Weizmann Institute reported engineered immune cells that target and reduce toxic brain proteins linked to neurodegeneration. Using...

A Nature Communications paper from Zhang, Ma, Wan and colleagues identifies histone lactylation as an epigenetic driver of immune evasion in pancreatic ductal adenocarcinoma. The work shows...

IRB Barcelona launched Spain’s first fully integrated Spatial Omics Platform to provide high‑throughput spatial transcriptomics and proteomics for biomedical research. The platform consolidates...