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FDA gene therapy review path for autoimmune CAR-T
Kyverna Therapeutics has begun a rolling submission to the FDA for miv-cel, after the agency requested additional natural history analysis. The company said the added work is intended to support...
Precision diagnostics: liquid biopsy for tumor microenvironment and ICI response
LiquidCell Dx is developing a cfDNA-based methylation profiling assay, called LiquidTME, to predict responses to immune checkpoint inhibitors by interrogating cellular ecosystems tied to tumor...
FDA approval: first therapy for ultra-rare NRG1 fusion cholangiocarcinoma
Partner Therapeutics’ Bizengri has received FDA approval for advanced cholangiocarcinoma driven by NRG1 gene fusions, marking the first approved therapy for this ultra-rare genetic driver. Partner...
Clinical signal: CRISPR-modified CD33-deleted stem cell transplant in AML/MDS
A Phase I/II multicenter trial led by Washington University School of Medicine reported that a CRISPR-Cas9 CD33-deleted allogeneic hematopoietic cell transplant can reduce recurrence risk in...
Oncology efficacy readout: MYTHIC trial in platinum-resistant ovarian cancer
The MYTHIC trial presented at UT MD Anderson’s clinical development updates showed activity for lunresertib plus zedoresertib in platinum-resistant ovarian cancer, including a precision...
AI drug discovery capital infusion: Isomorphic Labs Series B
Isomorphic Labs closed a $2.1 billion Series B to scale its AI drug-discovery engine and push more programs toward clinical entry. The round, described as a major milestone for AI-first drug...
Roche expands oncology diagnostics with PathAI acquisition
Roche moved to expand oncology diagnostics into an end-to-end platform strategy by pursuing acquisitions in digital pathology and MRD monitoring. At its diagnostics day, the company described...
Gene therapy development: AAV death investigation continues at Capsida
Capsida Biotherapeutics said it still does not know what caused a child’s death in a gene therapy trial of CAP-002, which delivered genes into the brain. The company said its investigation has...
FDA leadership change and shifting regulatory environment
FDA Commissioner Marty Makary has resigned, ending a turbulent tenure that included efforts to speed drug development and repeated controversy over agency management and scientific oversight....
FDA and EU expansion of Alzheimer’s blood diagnostics
Roche secured CE marking in Europe for its Elecsys plasma pTau217 blood test, intended to help rule in and rule out amyloid pathology. The company developed the test with Eli Lilly, adding another...
Roche’s oncology diagnostics push via acquisitions and sequencing instrument rollout
Roche used its diagnostics day to outline a strategy to become an end-to-end oncology solutions provider, spanning early detection through therapy selection and monitoring. Executives highlighted...
Obesity drug strategy and dose optimization entering the evidence base
Eli Lilly pointed to lower-dose and maintenance approaches for its obesity medicines, framing dose reduction as a potential option for sustaining weight loss while managing safety and cost...
Obesity maintenance data reinforce transition from injectable to oral therapy
A clinical program presented at ECO2026 and published in Nature Medicine reported that sustained weight loss appears achievable by moving patients from injectable obesity drugs to daily oral...
AI biotech funding surge for drug design platforms
Isomorphic Labs closed a $2.1 billion Series B, one of the largest rounds in biotech history, to expand its AI-driven drug design engine and accelerate pipeline development. The round was led by...
Major pharma partnership with Hengrui for early-stage pipeline growth
Bristol Myers Squibb and Hengrui Pharma entered a broad drug research collaboration covering 13 early development programs across oncology, hematology, and immunology. BMS will pay $600 million...
Targeted cancer therapy signals in ovarian cancer precision medicine trial
Data from the MYTHIC trial presented at a conference setting reported a 60% objective response rate at the proposed recommended phase 2 dose (RP2D) in patients with CCNE1-amplified...
Cancer diagnostics patent litigation keeps pressure on spatial biology platforms
10x Genomics and Harvard University sued Element Biosciences over alleged infringement tied to Element’s AVITI24 multiomics platform and related workflows. The complaint asserts infringement of...
Gene therapy development expands in autoimmune CAR-T pathway
Kyverna Therapeutics began a rolling submission to the FDA for its autoimmune CAR-T program miv-cel after additional natural history analysis requested by the agency. The company positioned...
FDA leadership shake-up
FDA Commissioner Marty Makary resigned, ending a turbulent tenure that included efforts to speed drug development and repeated turnover in senior roles. President Trump confirmed Makary’s...
Big Pharma-China pipeline expansion
Bristol Myers Squibb and Hengrui Pharma launched a global research pact spanning 13 early development programs across oncology, hematology and immunology, with deal terms reported as up to $15.2...