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FDA amends Xeloda label: pre‑treatment DPYD genetic testing now recommended
The U.S. Food and Drug Administration updated the boxed warning for Genentech’s capecitabine (Xeloda) to explicitly recommend pre‑treatment DPYD genetic testing to identify patients with...
Intellia gives clinical update on in vivo gene editing programs at ESGCT
Intellia Therapeutics presented a clinical update at the ESGCT meeting reporting progress across its in vivo lipid nanoparticle (LNP) gene editing programs. CSO Birgit Schultes highlighted...
ARPA‑H funds seven teams to accelerate in‑vivo cell and gene therapies
The Advanced Research Projects Agency for Health (ARPA‑H) awarded funding to seven teams to advance in‑vivo therapies designed to program immune cells and other cell types directly inside the...
Lexeo’s Friedreich ataxia gene therapy eyed for accelerated approval path
Lexeo Therapeutics reported positive interim data for LX‑2006, a cardiomyopathy gene therapy for Friedreich ataxia, and said U.S. FDA discussions indicated the program may be eligible for an...
Chiesi-Arbor pact: up to $2.1B to develop liver gene editing
Chiesi Group and Arbor Biotechnologies agreed an exclusive collaboration and license to develop Arbor’s lead in vivo gene‑editing candidate ABO‑101 and access Arbor’s editing platform, in a deal...
Intellia clinical update: in vivo edits show durable knockdown
Intellia Therapeutics provided a clinical update on its in vivo lipid‑nanoparticle (LNP) gene‑editing programs at ESGCT, focusing on NTLA‑2002 and lonvo‑z. CSO Birgit Schultes reported that...
FDA clears Boehringer’s Jascayd: first new IPF drug in a decade
The U.S. Food and Drug Administration approved Boehringer Ingelheim’s nerandomilast, branded Jascayd, for idiopathic pulmonary fibrosis (IPF)—the first new FDA approval in the indication in over...
Sanofi’s AlphaMedix hits Phase 2 goals—alpha radioligand shows responses
Sanofi, working with Orano Med (and partners RadioMedix/Orano), reported that its alpha‑emitting radioligand AlphaMedix met primary endpoints in a Phase 2 study for unresectable or metastatic...
Lexeo pursues accelerated path: FDA open to pooled‑data submission
Lexeo Therapeutics said U.S. FDA discussions positioned its LX‑2006 gene therapy for Friedreich ataxia (FA) to pursue an accelerated approval pathway if the company submits pooled data from...
Serial tumor biopsies: real‑time sampling reveals hidden GBM responses
Two independent reports showed serial, longitudinal tumor sampling in recurrent glioblastoma (rGBM) exposes therapy effects and immune responses that standard MRI failed to reveal. Break Through...
Nilo raises $101M: targeting brain‑body circuits to reset immunity
Nilo Therapeutics closed a $101 million Series A to develop small‑molecule drugs that target neural circuits regulating systemic inflammation. The preclinical startup was founded on...
ARPA‑H backs in‑vivo cell and gene therapy projects to reprogram immunity
The Advanced Research Projects Agency for Health (ARPA‑H) awarded funding to seven teams to accelerate in‑vivo approaches that program immune cells directly inside the body. The grants target...
Programmable proteins... logic gates steer therapeutics to their targets
Researchers at the University of Washington reported a platform for engineering therapeutic proteins that incorporate logical decision‑making to restrict activity to desired tissues. These...
Owlstone gets $49.1M ARPA‑H award to build at‑home multi‑cancer test
Owlstone Medical won up to $49.1 million from ARPA‑H to develop over‑the‑counter, at‑home breath tests capable of detecting more than 30 cancers at early (stage I) disease. The funding aims to...
Chiesi–Arbor pact targets PH1: $2.1B gene‑editing collaboration
Chiesi Group struck an exclusive collaboration and license with Arbor Biotechnologies to develop ABO‑101, an in‑vivo CRISPR gene‑editing candidate for primary hyperoxaluria type 1 (PH1), in a deal...
FDA clears Jascayd for IPF: first new pill in more than a decade
The US Food and Drug Administration approved Boehringer Ingelheim’s nerandomilast, marketed as Jascayd, for idiopathic pulmonary fibrosis (IPF), the first new approval in the indication in over...
Nilo launches with $101M: neuro‑immune startup aims to reset inflammation
Nilo Therapeutics launched with a $101 million Series A to develop small molecules that target defined neural circuits controlling systemic inflammation. The New York‑based preclinical company,...
Arthrosi nets $153M: bankroll to finish two Phase 3 gout trials
Arthrosi Therapeutics closed a $153 million Series E to complete two fully enrolled Phase 3 trials of its URAT1 inhibitor pozdeutinurad (AR882) as an oral treatment for gout. The San Diego biotech...
Real‑time tumor biopsies expose hidden glioblastoma responses – study
Serial, multi‑omics tumor biopsies in patients with recurrent glioblastoma uncovered robust intratumoral immune and pharmacodynamic signals that MRI and routine clinical metrics missed, according...
Lexeo lines up accelerated path for Friedreich ataxia gene therapy
Lexeo Therapeutics said discussions with the US FDA have positioned its LX‑2006 gene therapy for Friedreich ataxia cardiomyopathy on an accelerated approval pathway if pooled data from ongoing...