Pops Diabetes Care said this week that the FDA cleared its Pops! one blood glucose monitoring system. The Minneapolis-based company’s device can be attached directly to the back of a mobile phone and interacts with the user through a coaching app. The Pops! one system also allows users to review their blood glucose trends and […]
Ocular Therapeutix wins FDA nod for drug-delivery eye insert
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA approved its resubmitted application Dextenza, an ocular insert designed to release dexamethasone to relieve pain following ophthalmic surgery. The regulatory win for the Bedford, Mass.-based company comes after much back-and-forth with the FDA; the agency has twice rejected Ocular Therapeutix’s application for Dextenza. The company’s device is designed […]
FDA issues revised draft guidances for blood glucose monitors
The FDA issued two revised draft guidances today relating to over-the-counter and prescription blood glucose monitors. The new documents, which are intended to update guidances issued in 2016, were based on feedback from stakeholders, who requested more clarification on design considerations and recommended standards, according to the U.S. regulatory agency. The guidances include recommendations for […]
FDA approves Genentech’s prefilled autoinjector for Actemra
Roche‘s (OTC:RHHBY) Genentech said today that the FDA approved its ACTPen single-dose prefilled autoinjector for Actemra as a new formulation for adults with moderate to severe active rheumatoid arthritis and for adults with giant cell arteritis. The U.S. regulatory agency also approved the device for administration by caregivers to patients as young as two years old […]
Medtronic’s insulin pumps highlighted in medtech injury report
A new report published this week by the International Consortium of Investigative Journalists and media organizations around the world took aim at medical device companies and the regulations that govern the $400 billion industry. And in a related report about Medtronic (NYSE:MDT), the authors zero in on the company’s diabetes unit and its insulin pumps. Over the […]
Fresenius Kabi recalls sodium chloride injections over latex concern
Fresenius Kabi USA voluntarily recalled 163 lots of sodium chloride injections last week, noting that the product contains latex despite an insert that states otherwise. The company’s recall includes 0.9% injections in 10 mL vials and 20 mL vials. The product insert and the tray label for both kinds of vials say that the products’ stoppers […]
FDA extends decision date for Sage’s postpartum depression injection
Sage Therapeutics (NSDQ:SAGE) said today that the FDA extended its decision date for Sage’s Zulresso brexanolone injection to March 19, 2019. The U.S. regulatory agency was previously slated to decide whether or not to approve the drug as a treatment for postpartum depression by Dec. 19. The Cambridge, Mass.-based company noted that the FDA elected to […]
FDA warns on pain drugs for implantable pumps
The FDA today warned doctors and patients about the serious complications that can occur when using the wrong painkillers with implantable drug pumps. Dosing errors, pump failure, and infection are just some of the potential problems that can crop up when using drugs that aren’t approved for use with particular devices, the regulatory agency said. […]
FDA approves over-the-counter Primatene Mist inhaler
The FDA this week approved Amphastar Pharmaceuticals‘ (NSDQ:AMPH) over-the-counter Primatene Mist inhaler for the temporary relief of mild symptoms of intermittent asthma. The original version of Amphastar’s Primatene Mist device was taken off the market in 2011 because it contained chlorofluorocarbon propellants – a chemical compound that is linked to depletion of the Earth’s ozone […]
Senseonics wins another FDA approval for its implantable CGM
Senseonics (NYSE:SENS) said this week that it won another FDA approval for its implantable continuous glucose monitoring system, giving nurse practitioners and physicians assistants the ability to implant and remove the Eversense device. When the product was first approved by the FDA in June, only trained physicians were allowed to conduct the sensor insertion and removal […]
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