Baxter (NYSE:BAX) announced today that it received FDA approval for its premix norepinephrine bitartrate in 5% dextrose injection. Deerfield, Illinois-based Baxter launched the norepinephrine injection following the approval for raising blood pressure in adult patients with severe, acute hypotension (low blood pressure). According to a news release, the company’s formulation of norepinephrine is the first […]
FDA
Welldoc wins expanded FDA clearance for BlueStar insulin dosing platform
Welldoc announced today that it received another FDA 510(k) clearance for its BlueStar diabetes treatment platform. Columbia, Maryland-based Welldoc’s new clearance for BlueStar — the ninth in total — expands insulin dosing support to most types of insulin, including bolus and premixed insulin titration for type 2 diabetes. Previous FDA clearances include in June 2020 […]
FDA approves first Lucentis injection biosimilar for treating eye diseases
The FDA announced today that it approved Samsung Bioepis’ Byooviz injection, making it the first approved biosimilar to Lucentis for treating eye diseases. Byooviz (ranibizumab-nuna) is the first biosimilar to Lucentis (ranibizumab injection). It treats several eye diseases and conditions, including neovascular (wet) age-related macular degeneration (nAMD). The treatment involves an intravitreal injection (delivered into […]
FDA approves Impel NeuroPharma’s nasal spray for treating migraines
Impel NeuroPharma (NSDQ:IMPL) announced today that the FDA approved its Trudhesa nasal spray for treating migraine in adults. Seattle-based Impel NeuroPharma plans to launch Trudhesa commercially early next month. The company’s shares took a massive hit, though, dropping -19.3% at $18.65 per share by market close and continuing to slide down -0.8% at $18.50 after […]
Glaukos submits supplemental PMA application for iStent Infinite
Glaukos (NYSE:GKOS) announced today that it submitted a supplemental premarket approval application to the FDA for its iStent Infinite system. San Clemente, California–based Glaukos designed the iStent Infinite trabecular micro-bypass system for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma uncontrolled by prior surgery or medical therapy. […]
Baxter working on software upgrade for serious Spectrum IQ problems
Baxter (NYSE:BAX) this week issued an urgent medical device correction for all of its Spectrum IQ infusion pumps. Earlier this month, FDA designated a recall of Baxter’s Dose IQ safety software program as Class I, its most serious level. Baxter designed the Dose IQ as a standalone computer-based software program that allows care providers to […]
FDA approves supplemental new drug application for Xeris’ hypoglycemia treatment
Xeris Pharmaceuticals (NSDQ:XERS) announced today that the FDA approved its supplemental new drug application for the Gvoke kit. Chicago-based Xeris’ Gvoke (Ogluo in Europe) a ready-to-use pre-mixed, pre-measured glucagon injection for treating severe hypoglycemia for people with diabetes ages 2 and above. The kit will be available as a 1 mg/0.2 mL single dose vial […]
FDA approves, expands label for Eli Lilly’s rapid-acting insulin for infusion
Eli Lilly (NYSE:LLY) announced today that it received FDA approval and expanded labeling for its Lyumjev rapid-acting insulin. Indianapolis-based Eli Lilly’s Lyumjev (insulin lispro-aabc injection) 100 units/mL holds indication to improve glycemic control in adults with type 1 and type 2 diabetes, including administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump. The […]
Baxter has a serious recall involving infusion pump software
The FDA issued a Class I recall — the most serious kind of recall — for Baxter’s Dose IQ safety software program. Baxter designed its Dose IQ safety software as a standalone computer-based software program that allows care providers to create a drug library of pre-programmed dosing information for specific medications, which are delivered into […]
Vaxart stock soars after FDA approves IND application for oral COVID-19 vaccine tablet
Vaxart (NSDQ:VXRT) announced today that the FDA cleared the investigational new drug (IND) application for its oral COVID-19 vaccine. Upon news of the IND application approval for the S-only protein construct-based vaccine candidate, shares of VXRT were up 16.1% at $8.35 in early-morning trading today. South San Francisco-based Vaxart’s S+N oral tablet SARS-CoV-2 vaccine candidate […]