Latest Biotech News

Caribou released data suggesting its off‑the‑shelf cell therapy platform produced complete and durable responses in advanced B‑cell lymphoma patients, supporting continued development of...

TScan Therapeutics is laying off about 30% of staff and stopping a Phase I solid‑tumor T‑cell receptor trial to prioritize blood‑cancer programs and preserve runway. The company told investors it...

George Tidmarsh resigned as director of the FDA’s Center for Drug Evaluation and Research after being placed on administrative leave amid an HHS investigation into his conduct. The departure...

UniQure said the FDA has signaled that data from its Phase I/II studies of AMT‑130, a gene therapy for Huntington’s disease, may no longer be sufficient to support a Biologics License Application....

Pfizer filed lawsuits seeking to stop Metsera from terminating its merger agreement and from accepting Novo Nordisk’s counter‑offer, alleging breach of contract and antitrust harms. The legal...

Thermo Fisher Scientific agreed to acquire Clario, a clinical‑trial data and endpoint technology firm, for about $8.8–$9 billion to expand its digital capabilities in clinical research. The...

A Milan‑based gene‑therapy developer, AAVantgarde, closed a $141 million Series B round led in part by Amgen Ventures to advance gene therapies for inherited retinal diseases. The financing will...

Caribou Biosciences presented early clinical data showing its off‑the‑shelf CAR‑T candidate induced high complete‑response rates in advanced B‑cell lymphoma, with outcomes comparable to...

Sarepta Therapeutics reported that a confirmatory study of two exon‑skipping therapies for Duchenne muscular dystrophy missed its primary endpoint. Despite the negative result, Sarepta plans to...

Researchers announced a new record for rapid whole‑genome sequencing, completing a human genome in under four hours. The speed milestone aims to shorten diagnostic timelines for critically ill...

Investigators at Weill Cornell Medicine developed a versatile, non‑toxic gene‑switch tool that lets researchers turn target genes on or off using a benign small molecule. The platform—designed for...

Eli Lilly announced plans to invest $3 billion to build a manufacturing facility in Katwijk, the Netherlands, to produce its oral GLP‑1 candidate orforglipron and other small‑molecule assets. The...

George Tidmarsh resigned as director of the FDA’s Center for Drug Evaluation and Research after being placed on administrative leave while the Department of Health and Human Services investigates...

uniQure said a recent pre‑BLA meeting with the U.S. Food and Drug Administration signaled the agency no longer views Phase I/II data using an external control as sufficient to support a biologics...

Pfizer filed multiple lawsuits in Delaware seeking to block Novo Nordisk’s attempt to acquire obesity biotech Metsera, alleging breach of contract and an anticompetitive plot to eliminate a U.S....

Thermo Fisher Scientific agreed to acquire Clario for $8.8 billion to add clinical‑trial data capture, management and endpoint‑adjudication software to its Laboratory Products and Biopharma...

Roche struck a research and license deal with Manifold Bio to develop next‑generation 'brain shuttles' aimed at improving delivery of biologics across the blood‑brain barrier. The agreement,...

Eli Lilly announced a $3 billion manufacturing site in Katwijk, the Netherlands, to produce its oral GLP‑1 candidate orforglipron and other medicines. The plant expands Lilly’s European production...

Myriad Genetics reported a year‑over‑year revenue decline in Q3 but outlined product launches it expects to drive growth, including an expanded MyRisk hereditary cancer panel, a Polaris prostate...

California’s Medi‑Cal expanded coverage effective Nov. 1 to include personalized plasma tumor‑informed MRD testing, whole‑genome sequencing for rare disease diagnosis and multiple genome‑wide...