FDA has accepted Kowa’s NDA for NCX 470 and set an April 30, 2027 PDUFA date after two Phase 3 trials established noninferiority to latanoprost in lowering intraocular pressure.
Revolution Medicines’ once-daily daraxonrasib improved median overall survival to 13.2 months from 6.7 months with chemotherapy in RASolute 302, giving metastatic pancreatic adenocarcinoma its first FDA-approved broad RAS-targeted therapy.
Masimo’s FDA-cleared Root with LiDCO combines cardiac output, SpHb and oxygen saturation to continuously trend calculated oxygen delivery during major surgery and other periods of physiological stress.
Libre Duo 10 Day continuously measures glucose and ketones every minute for people with diabetes aged two and older, creating the first US integrated glucose-ketone monitoring category.
Global HARMONi data show ivonescimab plus chemotherapy reduced progression or death risk by 48% after third-generation EGFR-TKI failure, while overall survival had not reached statistical significance at the primary analysis.
FDA has approved two Ziihera-based first-line regimens in HER2-positive advanced gastroesophageal adenocarcinoma after the Tevimbra combination improved median overall survival from 19.2 to 26.4 months.
Tempus ECG-PH analyzes routine 12-lead ECGs from symptomatic adults aged 40 and older and returns a binary signal associated with elevated pulmonary artery pressure, but it is not a stand-alone diagnosis.
FDA has accepted United Therapeutics’ ralinepag NDA with a June 24, 2027 PDUFA date after ADVANCE OUTCOMES showed a 55% reduction in first clinical worsening events.
FDA has cleared Freyja Healthcare’s second-generation VereSee, combining a 2 mm miniature laparoscope with visual entry technology intended to show anatomy during initial laparoscopic access.
Nipro’s newly FDA-cleared ELISIO-HX is designed to remove larger uremic middle molecules while retaining essential proteins and working with existing hemodialysis infrastructure.