In May, Novo Nordisk announced that it voluntarily recalled 1,468 product samples related to its Levemir, Tresiba, Fiasp, Novolog and Xultophy insulin lines. The products were held at sub-freezing temperatures, prompting the FDA to recently classify the recalls as Class I. FDA uses the Class I designation for situations where there is “a reasonable probability” […]
FDA
Cardinal Health wins new FDA approval for Lymphoseek
Cardinal Health (NYSE:CAH) announced today that the FDA approved its Lymphoseek injection for pediatric use. Dublin, Ohio-based Cardinal Health touts Lymphoseek — acquired from Navidea Biopharmaceuticals (NYSE:NAVB) in November 2016 — as the first and only radiopharmaceutical agent specifically designed for targeted lymphatic mapping and guiding sentinel lymph node biopsies (SLNB). The new indication will expand […]
Glaukos completes enrollment in Phase 3 trials for iDose TR drug-eluting implant
Glaukos (NYSE:GKOS) announced today that it completed enrollment for a Phase 3 clinical program for its iDose TR sustained-release travoprost implant. San Clemente, Calif.–based Glaukos’ iDose TR implant contains a novel formulation of travoprost, a prostaglandin analog used to reduce intraocular pressure (IOP) through a design that continuously releases therapeutic levels of the medication for […]
FDA accepts resubmitted NDA for Xipere from Clearside Biomedical, Bausch Health
Bausch Health (NYSE:BHC) and Clearside Biomedical (NSDQ:CLSD) announced today that the FDA accepted their resubmitted new drug application for Xipere. Clearside Biomedical designed the investigational Xipere triamcinolone acetonide suprachoroidal injectable suspension therapy with a proposed indication for treating macular edema associated with uveitis. Xipere works with Clearside’s proprietary SCS Microinjector to access the back of […]
BD applicators cited in medical kit recall
A medical care kit company is recalling more than 8,200 kits because they contain BD applicators that may become contaminated with a fungus. The recall by Medical Action Industries covers certain of its 306 Medical Convenience Kits, distributed between December 12, 2019, and March 22, 2021, according to the FDA. The agency has labeled the […]
FDA issues draft clinical trial guidelines for neurostim, other devices to treat diabetes
The FDA today issued a draft guidance with recommendations for clinical trials for certain devices intended for treating diabetes. Included in the guidance are recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with type 2 diabetes mellitus, independent of medication delivery. Among the […]
FDA accepts IND application for Samus Therapeutics’ oral glioma drug
Samus Therapeutics announced today that the FDA cleared its investigational new drug (IND) application for its glioma treatment. Boston-based Samus Therapeutics develops the PU-AD (icapamespib) orally administered small molecule drug for the treatment of recurrent malignant glioma, according to a news release. Under the IND, Samus will move forward with its Phase 1b study to […]
BD’s Alaris pump hit with another serious recall
A medical supply company is recalling BD (NYSE:BDX) Alaris infusion pumps — the third Class I recall for the pumps in recent months, according to the FDA. North Carolina-based Avante Health Solutions issued the Alaris pump recall March 24, 2021, because the bezel repair posts may crack or separate, leading to the inaccurate delivery of […]
FDA approves higher dosage of naloxone nasal spray
The FDA announced today that it approved a higher dose of naloxone hydrochloride nasal spray to treat opioid overdose. Previously, the FDA had approved 2 mg and 4 mg naloxone nasal spray products, but the newly approved product — Kloxxado from Hikma Pharmaceuticals — delivers 8 mg of naloxone into the nasal cavity, according to […]
FDA grants breakthrough nod for Fractyl’s type 2 diabetes treatment
Fractyl Laboratories announced today that it received FDA breakthrough device designation for its Revita DMR type 2 diabetes treatment. Lexington, Mass.-based Fractyl’s Revita DMR treatment is an outpatient endoscopic procedure designed to resurface the upper intestine lining (duodenal mucosa) in metabolic disease for patients with insulin-treated type 2 diabetes. Preliminary clinical findings suggest that the […]