Corium (NSDQ:CORI) announced today that it received FDA approval for its once-daily Azstarys oral capsule for treating ADHD symptoms. Boston-based Corium touts its Azstarys (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) drug as the first and only product containing a d-MPH oral prodrug for treating ADHD (attention deficit hyperactivity disorder) symptoms in patients aged six years and older, […]
Food & Drug Administration (FDA)
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 […]
DTx Pharma completes $100M Series B
RNA-based therapeutic developer DTx Pharma announced today that it completed a $100 million Series B financing round. RA Capital Management led the financing round with participation from new investors Access Biotechnology, Surveyor Capital (a Citadel company), Cormorant Asset Management, Janus Henderson Investors, and Logos Capital. Additionally, existing investors Friedman Bioventure Fund, Eli Lilly, Viva BioInnovator […]
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 […]
United Therapeutics launches Remunity pump for Remodulin
United Therapeutics (NSDQ:UTHR) announced today that it launched its Remunity pump for Remodulin in patients with pulmonary arterial hypertension (PAH). Research Triangle Park, N.C.-based United Therapeutics’ Remunity pump initially received FDA clearance in May 2019 for patient filling, adding another 510(k) clearance in February 2020 to enable cassettes to be prefilled with Remodulin by contracted […]
Surmodics’ DCB shown non-inferior to Medtronic’s In.Pact Admiral
Surmodics (NSDQ:SRDX) announced data showing that its SurVeil drug-coated balloon is non-inferior to Medtronic’s In.Pact Admiral. Eden Prairie, Minn.-based Surmodics’ 12-month data from the Transcend clinical trial, presented at the Leipzig Interventional Course 2021 virtual event, revealed primary results that found the SurVeil DCB is non-inferior to In.Pact Admiral in both safety and efficacy while delivering […]
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 […]
Alaris remediation could cost BD up to $244M
Becton Dickinson (NYSE:BDX) in its most recent fiscal year set aside $244 million to cover future product remediation costs, including the company’s work to fix its problematic Alaris infusion pumps. The Franklin Lakes, N.J.–based company has had shipments of the pumps on hold since early this year, when FDA called for a comprehensive 510(k) submission to […]
