The FDA has identified another recall for the Alaris infusion pump from BD (NYSE:BDX) as Class I, the most serious kind of recall. BD’s latest recall, initiated on March 3, 2021, involves its BD Alaris infusion pump module system, which includes an infusion pump and vital signs monitoring system with a PC unit, the Guardrails […]
FDA
Genentech wins FDA approval for Xolair prefilled syringe
Genentech announced today that the FDA approved its supplemental biologics license application for the Xolair prefilled syringe. South San Francisco-based Genentech touts the Xolair (omalizumab) prefilled syringe for self-injection across all approved U.S. indications as the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for treating moderate to severe persistent allergic asthma, […]
FDA approves inhaled pulmonary hypertension treatment from United Therapeutics
United Therapeutics (NSDQ:UTHR) announced today that it received FDA approval for its Tyvaso inhalation solution for pulmonary hypertension. Research Triangle Park, N.C.-based United Therapeutics’ Tyvaso (treprostinil) inhalation solution is designed to treat patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability, according to a news release. With approval, Tyvaso now […]
BlueStar Genomics gains breakthrough nod for pancreatic cancer test
Bluestar Genomics announced today that it received FDA breakthrough device designation for its pancreatic cancer test. San Diego-based Bluestar’s proprietary noninvasive pancreatic cancer detection test is designed for use with patients with new-onset diabetes, according to a news release. The test uses a standard blood draw to assess whether an individual has an abnormal epigenomic […]
FDA tentatively approves first generic version of Symbicort inhalation aerosol
Viatris (NSDQ:VTRS) and Kindeva Drug Delivery announced today that the FDA granted tentative approval of the first generic version of Symbicort. Symbicort, an inhalation aerosol is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD). The drug had U.S. branded sales of $3.5 billion for the 12 months ended January 2021, according […]
FDA accepts New Drug Application for Eyenovia pupil dilation tech
Eyenovia (NSDQ:EYEN) announced today that the FDA accepted its New Drug Aplication for its MydCombi pupil dilation agent. MydCombi is a fixed-combination mydriatic agent for potential use in comprehensive eye exams with a formulation for touchless fixed-combination microdosing in an effort to improve the patient experience, according to a news release. New York-based Eyenovia’s proprietary Optejet […]
FDA approves Oncopeptides treatment for multiple myeloma
Oncopeptides (STO:ONCO) announced today that it received FDA approval for its Pepaxto treatment for multiple myeloma. Waltham, Mass.-based Oncopeptides’ Pepaxto (melphalan flufenamide) received approval in combination with dexamethasone for treating adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at […]
Looking back at two decades of CGM advances
Continuous glucose monitors (CGMs) have transformed how many people with diabetes manage blood sugar, but attempts to monitor blood glucose have a long history. Attempts to manage glucose kicked off in earnest when researchers began measuring glucose in urine in the mid-1800s. Scientists’ ability to do so steadily improved over the years, but urine glucose […]
Eitan Medical lands FDA clearance for infusion pump system upgrade
Eitan Medical (formerly Eitan Group) announced today that the FDA has granted 510(k) clearance to its upgraded Sapphire infusion pump system software Rev15, which includes the infusion pump, administration sets and accessories. The Sapphire infusion system is the company’s flagship infusion device and is used across the U.S. within alternate sites, homecare markets, emergency medical […]
Locate Bio lands FDA breakthrough nod for bone infection device
Regenerative medicine company Locate Bio announced today that the FDA has granted breakthrough device designation to a bone graft/antibiotic combination designed to combat chronic bone infection, also known as osteomyelitis. Osteomyelitis is a progressive, inflammatory infection of the bone, usually caused by bacteria and is estimated to account for up to 50% of all non-trauma […]
