fda

An FDA panel voted 10-3 that IGNYTE trial results for RP1 plus nivolumab are clinically meaningful, days ahead of an August 2 decision.

Otsuka's Simtriyo (centanafadine) becomes the first approved norepinephrine-dopamine-serotonin reuptake inhibitor for ADHD, backed by four Phase 3 trials, with a boxed warning and DEA scheduling still pending.

EndoQuest Robotics finished enrolling 49 subjects in its pivotal PARADIGM trial for robotic colorectal lesion removal, citing a 100% en bloc resection rate.

FDA cleared the IND for FT839, an off-the-shelf CAR T-cell candidate co-targeting CD19 and CD38 across five autoimmune diseases without chemotherapy conditioning.

The FDA cleared a subcutaneous, wearable-device formulation of Sanofi's multiple myeloma drug Sarclisa, the first cancer therapy approved for on-body injector delivery.

Absentia Labs says its AI-driven Digital Liver Model is the first AI drug-development tool accepted into the FDA's ISTAND qualification pathway, at the Letter of Intent stage, to predict drug-induced liver injury.

Taysha Gene Therapies has finished dosing 17 patients in the pivotal REVEAL trial of its Rett syndrome gene therapy TSHA-102 and reported longer-term Phase 1/2 data, setting up a planned BLA filing after a six-month interim analysis.

The FDA approved expanded use of Vertex's CRISPR therapy Casgevy for patients as young as 2 with sickle cell disease or transfusion-dependent beta thalassemia, making roughly 5,500 more U.S. children eligible.

Tregzi lifted 12-month chronic-GVHD-free survival to 78% from 38% in the 187-patient Precision-T trial, becoming the first Treg-based immunotherapy the FDA has cleared.

The FDA cleared EchoNext, a deep-learning tool that reads a routine 12-lead ECG to flag six forms of hidden structural heart disease, outperforming cardiologists in a Nature study.

Cogent's bezuclastinib plus sunitinib reached 16.5-month median PFS versus 9.2 months in second-line GIST, with FDA Priority Review and a November 30 PDUFA date.

After a December 510(k) clearance for cholecystectomy, the UK firm is commercializing Versius Plus in the US and has applied to add benign gynecology procedures.