Combination drug-device https://www.bioworld.com/rss en-us Redemption for Lyra as second phase III rhinosinusitis trial hits goal http://www.bioworld.com/articles/720816 Mon, 02 Jun 2025 11:00:00 -0400 https://www.bioworld.com/articles/720816-redemption-for-lyra-as-second-phase-iii-rhinosinusitis-trial-hits-goal LYR-210 device unfurling LYR-210 is a drug-device candidate for chronic rhinosinusitis. Credit: Lyra Therapeutics Inc. Sen. Cassidy: Time for US FDA to reclaim its Orange Book duties http://www.bioworld.com/articles/713107 Wed, 02 Oct 2024 12:00:00 -0400 https://www.bioworld.com/articles/713107-sen-cassidy-time-for-us-fda-to-reclaim-its-orange-book-duties Device patents still listed, FTC embraces chance to expand review http://www.bioworld.com/articles/709893 Mon, 24 Jun 2024 12:00:00 -0400 https://www.bioworld.com/articles/709893-device-patents-still-listed-ftc-embraces-chance-to-expand-review Lyra sinks as rhinosinusitis drug-device misses in phase III http://www.bioworld.com/articles/708333 Mon, 06 May 2024 12:00:00 -0400 https://www.bioworld.com/articles/708333-lyra-sinks-as-rhinosinusitis-drug-device-misses-in-phase-iii LYR-210 device unfurling LYR-210 is a drug-device candidate for chronic rhinosinusitis. Credit: Lyra Therapeutics Inc. Debate over Orange Book device listings heard on multiple fronts http://www.bioworld.com/articles/708164 Wed, 01 May 2024 12:00:00 -0400 https://www.bioworld.com/articles/708164-debate-over-orange-book-device-listings-heard-on-multiple-fronts Will promised Orange Book guidance keep up with technology? http://www.bioworld.com/articles/705935 Tue, 20 Feb 2024 12:00:00 -0500 https://www.bioworld.com/articles/705935-will-promised-orange-book-guidance-keep-up-with-technology FDA issues complete response letter to Satsuma for migraine NDA over CMC issues http://www.bioworld.com/articles/704890 Tue, 23 Jan 2024 12:00:00 -0500 https://www.bioworld.com/articles/704890-fda-issues-complete-response-letter-to-satsuma-for-migraine-nda-over-cmc-issues FDA issues complete response letter to Satsuma for migraine NDA over CMC issues http://www.bioworld.com/articles/704776 Thu, 18 Jan 2024 12:00:00 -0500 https://www.bioworld.com/articles/704776-fda-issues-complete-response-letter-to-satsuma-for-migraine-nda-over-cmc-issues ITCA-650 beaten down by safety issues at EMDAC hearing http://www.bioworld.com/articles/701150 Thu, 21 Sep 2023 12:00:00 -0400 https://www.bioworld.com/articles/701150-itca-650-beaten-down-by-safety-issues-at-emdac-hearing Medici drug delivery system Medici drug delivery system. Credit: Intarcia Therapeutics Inc. Adcom a make-it-or-break-it hearing for combo diabetes product http://www.bioworld.com/articles/701091 Tue, 19 Sep 2023 12:00:00 -0400 https://www.bioworld.com/articles/701091-adcom-a-make-it-or-break-it-hearing-for-combo-diabetes-product Medici drug delivery system Medici drug delivery system. Credit: Intarcia Therapeutics Inc. SK Bioscience, Vaxxas partner to develop needle-free typhoid vaccine http://www.bioworld.com/articles/700444 Tue, 29 Aug 2023 12:00:00 -0400 https://www.bioworld.com/articles/700444-sk-bioscience-vaxxas-partner-to-develop-needle-free-typhoid-vaccine Vaxxas HD-MAP Vaxxas Pty Ltd.’s high-density microarray patch SK Bioscience, Vaxxas partner to develop needle-free typhoid vaccine http://www.bioworld.com/articles/700367 Fri, 25 Aug 2023 12:00:00 -0400 https://www.bioworld.com/articles/700367-sk-bioscience-vaxxas-partner-to-develop-needle-free-typhoid-vaccine Vaxxas HD-MAP Vaxxas Pty Ltd.’s high-density microarray patch Delcath gets FDA win for Hepzato Kit for metastatic uveal melanoma http://www.bioworld.com/articles/700058 Wed, 16 Aug 2023 12:00:00 -0400 https://www.bioworld.com/articles/700058-delcath-gets-fda-win-for-hepzato-kit-for-metastatic-uveal-melanoma Liver illustration Credit: Georgia State University Delcath gets FDA win for Hepzato Kit for metastatic uveal melanoma http://www.bioworld.com/articles/699966 Tue, 15 Aug 2023 12:00:00 -0400 https://www.bioworld.com/articles/699966-delcath-gets-fda-win-for-hepzato-kit-for-metastatic-uveal-melanoma Liver illustration Credit: Georgia State University Stakeholders prod FDA to include drugs in scope of device software functions guidance http://www.bioworld.com/articles/515963 Thu, 10 Feb 2022 13:00:00 -0500 https://www.bioworld.com/articles/515963-stakeholders-prod-fda-to-include-drugs-in-scope-of-device-software-functions-guidance Laptop displaying FDA logo FDA combo products guidance offers more flexibility for cross-labeling http://www.bioworld.com/articles/515622 Mon, 31 Jan 2022 13:00:00 -0500 https://www.bioworld.com/articles/515622-fda-combo-products-guidance-offers-more-flexibility-for-cross-labeling FDA website and logo Credit: Postmodern Studio - stock.adobe.com Cansino partners with Aerogen for inhalable COVID vaccine http://www.bioworld.com/articles/514267 Tue, 14 Dec 2021 13:42:00 -0500 https://www.bioworld.com/articles/514267-cansino-partners-with-aerogen-for-inhalable-covid-vaccine Cansino partners with Aerogen for inhalable COVID vaccine http://www.bioworld.com/articles/514121 Thu, 09 Dec 2021 12:00:00 -0500 https://www.bioworld.com/articles/514121-cansino-partners-with-aerogen-for-inhalable-covid-vaccine MHRA invites e-cigarette makers to submit their products for approval as medical devices http://www.bioworld.com/articles/512952 Tue, 02 Nov 2021 13:00:00 -0400 https://www.bioworld.com/articles/512952-mhra-invites-e-cigarette-makers-to-submit-their-products-for-approval-as-medical-devices Doctor holding an e-cigarette in one hand, tobacco cigarette in the other No happy ending for once-charmed biotech unicorn http://www.bioworld.com/articles/510990 Wed, 29 Sep 2021 12:00:00 -0400 https://www.bioworld.com/articles/510990-no-happy-ending-for-once-charmed-biotech-unicorn Medici drug delivery system Medici drug delivery system. Credit: Intarcia Therapeutics Inc. China clarifies rules for registration and classification of drug-device combinations http://www.bioworld.com/articles/510727 Tue, 24 Aug 2021 12:06:00 -0400 https://www.bioworld.com/articles/510727-china-clarifies-rules-for-registration-and-classification-of-drug-device-combinations Chinese flag China clarifies rules for registration and classification of drug-device combinations http://www.bioworld.com/articles/510620 Thu, 19 Aug 2021 12:00:00 -0400 https://www.bioworld.com/articles/510620-china-clarifies-rules-for-registration-and-classification-of-drug-device-combinations Chinese flag Visus signs deal to develop extended-release eye drugs with Delsitech http://www.bioworld.com/articles/510619 Thu, 19 Aug 2021 12:00:00 -0400 https://www.bioworld.com/articles/510619-visus-signs-deal-to-develop-extended-release-eye-drugs-with-delsitech Face with digital focus on eye Ace heart-wear store Scpharma wields proven tool for cardiac cost saving http://www.bioworld.com/articles/509317 Wed, 14 Jul 2021 12:00:00 -0400 https://www.bioworld.com/articles/509317-ace-heart-wear-store-scpharma-wields-proven-tool-for-cardiac-cost-saving Furoscix Furoscix drug delivery system. Credit: Scpharmaceuticals Inc. Savings from complex generics remain elusive in U.S. http://www.bioworld.com/articles/503406 Wed, 10 Feb 2021 11:00:00 -0500 https://www.bioworld.com/articles/503406-savings-from-complex-generics-remain-elusive-in-us Generic drugs and bottle Boston Scientific gets green light for Ranger DC http://www.bioworld.com/articles/499677 Mon, 02 Nov 2020 12:00:00 -0500 https://www.bioworld.com/articles/499677-boston-scientific-gets-green-light-for-ranger-dc Boston Scientific Ranger Drug-Coated Balloon Ranger Drug-Coated Balloon. Credit: Boston Scientific Stop and go at Inovio: Planned phase II/III of COVID-19 vaccine put on partial hold BioWorld that the company and its partners are continuing to prepare for the phase II/III trial “following resolution of the FDA’s partial clinical hold.”]]> http://www.bioworld.com/articles/498277 Mon, 28 Sep 2020 12:00:00 -0400 https://www.bioworld.com/articles/498277-stop-and-go-at-inovio-planned-phase-iiiii-of-covid-19-vaccine-put-on-partial-hold Doctor signaling timeout Innocoll gains FDA nod for drug-device pain therapy Xaracoll http://www.bioworld.com/articles/497183 Mon, 31 Aug 2020 11:45:00 -0400 https://www.bioworld.com/articles/497183-innocoll-gains-fda-nod-for-drug-device-pain-therapy-xaracoll Adhering to its guns, DBV seeks meeting with FDA on CRL for peanut allergy patch http://www.bioworld.com/articles/496452 Tue, 04 Aug 2020 12:00:00 -0400 https://www.bioworld.com/articles/496452-adhering-to-its-guns-dbv-seeks-meeting-with-fda-on-crl-for-peanut-allergy-patch Child pushing away bowl of peanuts Synairgen stock rockets as inhaled interferon-beta shows signs of efficacy in COVID-19 http://www.bioworld.com/articles/471739 Mon, 20 Jul 2020 12:00:00 -0400 https://www.bioworld.com/articles/471739-synairgen-stock-rockets-as-inhaled-interferon-beta-shows-signs-of-efficacy-in-covd-19 Patient in hospital bed