Latest Biotech News

Roche pushed its KRAS G12C program forward with new Phase 3 results that beat existing therapies in previously treated non-small cell lung cancer. The divarasib study, Krascendo-1, reported...

Celea Therapeutics raised $180 million to advance deupirfenidone, its next-generation idiopathic pulmonary fibrosis (IPF) therapy. The PureTech spinout, launched in 2025, positions the program as...

The FDA approved Orca Bio’s Tregzi, a personalized regulatory T-cell (Treg) therapy designed to reduce graft-versus-host disease complications after matched-donor allogeneic HSCT. The approval...

A U.S. District Court in Colorado halted a 70% price cap on Amgen’s Enbrel after granting the company a preliminary injunction. The decision came from Judge Daniel Domenico, who said the cap could...

Otsuka reported long-term Phase 3 data for Voyxact (now branded by the company for kidney disease indication), aiming to convert an accelerated approval into full approval. The company said the...

Hartwig Medical Foundation secured CE-IVDR certification for its OncoAct cancer whole-genome sequencing (WGS) analysis software, enabling hospitals to deploy the pipeline for solid tumor patients....

A new open-source tool for automated genomic reanalysis, Talos, helped diagnose rare disease patients by reinterpreting existing genome data with newly discovered gene–variant associations....

China-led clinical trial retractions are again putting data transparency and validation systems under the microscope. The latest examples—especially a retracted, high-profile China-led lung cancer...

FDA granted an investigational device exemption (IDE) for Adaptive Biotechnologies’ ClonoSeq assay to be used in Imviva Biotech’s TENACITY-01 trial of CTD402, an allogeneic anti-CD7 CAR T therapy....

Ipsen agreed to acquire Memo Therapeutics for about €700 million (US$797 million) upfront for potravitug, a monoclonal antibody candidate targeting BK virus-associated infections and nephropathy...

Hartwig Medical Foundation received CE-IVDR certification for its OncoAct cancer whole-genome sequencing (WGS) analysis software, enabling hospital laboratories to deploy the pipeline for...

Orca Bio’s Tregzi (an allogeneic, regulatory T cell–based approach) won U.S. approval to reduce transplant-related complications in patients with hematologic malignancies undergoing matched-donor...

Two separate developments intensified scrutiny of trial conduct and disclosure in high-impact oncology publishing. A Nature Medicine retraction targeted a high-profile China-led lung cancer study,...

Roche extended its KRAS lung cancer strategy with Phase 3 data indicating its KRAS G12C inhibitor divarasib outperformed marketed comparators in a head-to-head trial. In parallel, Roche’s...

Ipsen announced plans to acquire Memo Therapeutics for €700 million (about $797 million), bringing potravitug, a Phase 2/fast-track antibody targeting BK virus-associated infections in kidney...

Guardant Health’s Shield colorectal cancer screening test gained a coverage tailwind after UnitedHealthcare announced it will cover Shield as a first-line screening assay for average-risk adults...

A former FDA AI regulator turned industry executive argued that biopharma is misreading the agency’s intent on AI flexibility in medical product development. Speaking after joining Parexel, Tala...

A U.S. House Select Committee investigation expanded focus on clinical trials conducted by U.S. companies at Chinese military hospitals and in Xinjiang, raising questions about patient safety...

Evernorth committed $100 million through 2028 to build Pharmacy Forward, an AI-powered specialty pharmacy program aimed at improving specialty pharmacy operations and patient care. In parallel,...

Beeline Medicines raised €42.6 million as it advanced afimetoran in lupus and continued clinical development across its candidate pipeline, marking a clear continued appetite for immunology...