Virtual Incision has secured FDA 510(k) clearance for its miniature MIRA robotic-assisted surgery system in benign hysterectomy, extending the platform beyond colectomy into gynecologic surgery.
Amgen and AstraZeneca say TEZSPIRE achieved both co-primary and all key secondary endpoints in the Phase 3 CROSSING study, potentially extending the TSLP-blocking biologic into eosinophilic esophagitis.
Genentech has entered a global collaboration with DualityBio to develop antibody-drug conjugates using novel payloads designed to address tumors resistant to widely used topoisomerase inhibitor ADCs.
Generative artificial intelligence is pushing medical software beyond fixed predictions toward systems capable of conversation, synthesis and potentially autonomous actions. The FDA is now exploring whether these devices should be evaluated more like clinical professionals than conventional software.
Tempus AI has received FDA 510(k) clearance for ECG-PH, artificial-intelligence software that analyzes routine 12-lead electrocardiograms for signs associated with elevated pulmonary artery pressure in symptomatic adults without a known pulmonary-hypertension diagnosis.
CTX310 sustains deep ANGPTL3, LDL and triglyceride reductions for one year after one infusion. See what the data mean for CRISPR Therapeutics.
Aficamten hits both Phase 3 ACACIA-HCM endpoints as Cytokinetics prepares an FDA filing. See what the results mean for Myqorzo growth.
Abbott Laboratories has secured FDA De Novo authorization for Libre Duo 10 Day, the first wearable in the United States to continuously monitor ketones and the first device globally to continuously measure glucose and ketones together.
Gilead Sciences has secured U.S. Food and Drug Administration approval for Bixlenvo, a once-daily tablet combining bictegravir and lenacapavir for virologically suppressed adults with HIV, including patients whose resistance or treatment history has kept them on complex multi-tablet regimens.
The U.S. Food and Drug Administration has approved Priovant Therapeutics’ LISRAYA, or brepocitinib, for adults with dermatomyositis, creating the first FDA-approved oral treatment for the rare systemic autoimmune disease. The decision converts positive Phase 3 VALOR data into Roivant Sciences’ first commercial opportunity for a drug that is also being developed across several other immune-mediated