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 […]
Regulatory/Compliance
OncoSec wins CE mark for electroporation device to treat solid tumors
OncoSec Medical (NSDQ:ONCS) announced today that it received CE mark approval for its next-generation device to enable better uptake of anti-cancer therapies. GenPulse, part of OncoSec’s electroporation device platform for treating solid tumors, is designed to apply short electric impulses to a tumor, according to a news release. Get the full story at our sister site, […]
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, […]
Teva Pharmaceuticals receives European approval for Spiromax inhalers
Teva Pharmaceuticals announced today that it received European marketing authorization for its Seffalair and BroPair Spiromax inhalers. Seffalair Spiromax and its duplicate BroPair Spiromax (salmeterol xinafoate/ fluticasone propionate, 12.75/100 and 12.75/202 micrograms delivered doses) received approval as a maintenance treatment for asthma in adults and adolescents aged 12 years and older, according to a news […]
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 […]
BD expands recall of ChloraPrep 3 ml applicator
BD announced that it revised a previous press release from last week to expand a voluntary recall of its ChloraPrep 3 mL applicator. Franklin Lakes, N.J.-based BD initiated the recall for specified catalog numbers of the applicator device on June 23, 2020, due to possible fungal contamination under certain environmental conditions, according to a news […]
J&J Vision wins Japanese approval for first drug-releasing contact lens
Johnson & Johnson Vision announced that it received approval in Japan for its Acuvue Theravision lens with Ketotifen. The company touts the lens as the first and only vision-correcting contact lens that relieves allergic eye itch through drug delivery, according to a news release. Japan’s Ministry of Health, Labour and Welfare (MHLW) approved the lens, […]
Eitan Medical wins EU clearance for Sapphire infusion pump
Eitan Medical announced that it received European Union Medical Device Recognition (MDR) certification for its Sapphire infusion pump. Approval for the Sapphire infusion pump, along with its accessories and administration sets, was granted in January 2021, according to a news release. The certification is EU MDR 2017/45. Sapphire includes upgraded Rev15 software, also EU MDR […]
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 […]
