Novartis’ division Alcon has obtained CE-Mark for its AutonoMe preloaded intraocular lens (IOL) delivery system to accurately deliver the IOL into the capsular bag during cataract surgery. The AutonoMe system is preloaded with a new biomaterial called Clareon IOL that features an advanced design for sharp vision, low edge glare and enhanced optic clarity. With an automated CO2-powered delivery mechanism, the preloaded system is intended to enable accurate single-handed control of IOL placement. Alcon CEO Mike Ball said: “With the introduction of Clareon AutonoMe, we are proud to unveil our latest innovations to benefit doctors and their patients undergoing cataract surgery. “Clareon AutonoMe builds upon the comprehensive legacy of AcrySof by offering cataract surgeons easy, intuitive control of IOL delivery with the newest optic material.” “The intuitive and easy-to-use device is expected to simplify the procedure and minimise surgical time.” The intuitive and easy-to-use device is expected to simplify the procedure ...
The U.S. Food and Drug Administration(FDA) approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using a blood sample from the fingertip (often referred to as a “fingerstick”).
The U.S. Food and Drug Administration(FDA) approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy).
Novo Nordisk announced that the China Food and Drug Administration (CFDA) has approved Tresiba® (insulin degludec) for the treatment of diabetes in China. Tresiba® is a new-generation, once-daily basal insulin with an ultra-long duration of action which allows for flexibility in day-to-day dosing.
Merck, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.
Symbiomix Therapeutics announced the U.S. Food and Drug Administration (FDA) has approved its lead product Solosec™ (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women.
Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, announced that the European Commission(EC) has approved Xermelo® (telotristat ethyl) 250 mg three times a day (tid) for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
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