Breakthrough therapy https://www.bioworld.com/rss en-us Otsuka to acquire PTSD drugmaker Transcend in $1.2B deal http://www.bioworld.com/articles/730090 Tue, 31 Mar 2026 12:00:00 -0400 https://www.bioworld.com/articles/730090-otsuka-to-acquire-ptsd-drugmaker-transcend-in-12b-deal Brain with handshake and cityscape Otsuka to acquire PTSD drugmaker Transcend in $1.2B deal http://www.bioworld.com/articles/729952 Mon, 30 Mar 2026 12:00:00 -0400 https://www.bioworld.com/articles/729952-otsuka-to-acquire-ptsd-drugmaker-transcend-in-12b-deal Brain with handshake and cityscape D3 Bio raises $108M series B to move KRAS G12C into phase III http://www.bioworld.com/articles/727230 Tue, 16 Dec 2025 00:00:00 -0500 https://www.bioworld.com/articles/727230-d3-bio-raises-108m-series-b-to-move-kras-g12c-into-phase-iii KRAS protein KRAS protein. Credit: National Cancer Institute, NIH D3 Bio raises $108M series B to move KRAS G12C into phase III http://www.bioworld.com/articles/726892 Wed, 10 Dec 2025 12:00:00 -0500 https://www.bioworld.com/articles/726892-d3-bio-raises-108m-series-b-to-move-kras-g12c-into-phase-iii KRAS protein KRAS protein. Credit: National Cancer Institute, NIH Innovent rings up $11.4B deal with Takeda for three I-O/ADC assets http://www.bioworld.com/articles/725329 Wed, 22 Oct 2025 11:00:00 -0400 https://www.bioworld.com/articles/725329-innovent-rings-up-114b-deal-with-takeda-for-three-i-o-adc-assets Antibodies attacking cancer cell Allay’s $57.5M extends postsurgical pain relief with ATX-101 http://www.bioworld.com/articles/721154 Tue, 10 Jun 2025 11:00:00 -0400 https://www.bioworld.com/articles/721154-allays-575m-extends-postsurgical-pain-relief-with-atx-101 Knee pain illustration Allay’s $57.5M extends postsurgical pain relief with ATX-101 http://www.bioworld.com/articles/720951 Fri, 06 Jun 2025 11:00:00 -0400 https://www.bioworld.com/articles/720951-allays-575m-extends-postsurgical-pain-relief-with-atx-101 Knee pain illustration First Prader-Willi treatment Vykat XR FDA-approved: Soleno soars http://www.bioworld.com/articles/718567 Thu, 27 Mar 2025 16:00:00 -0400 https://www.bioworld.com/articles/718567-first-prader-willi-treatment-vykat-xr-fda-approved-soleno-soars Vykat XR Credit: Soleno Therapeutics Inc. Nature Cell wins FDA breakthrough designation of Jointstem http://www.bioworld.com/articles/718522 Tue, 25 Mar 2025 11:00:00 -0400 https://www.bioworld.com/articles/718522-nature-cell-wins-fda-breakthrough-designation-of-jointstem 3D illustration of mesenchymal stem cells Protagonist’s rusfertide hits phase III goals in rare leukemia http://www.bioworld.com/articles/717939 Wed, 05 Mar 2025 12:00:00 -0500 https://www.bioworld.com/articles/717939-protagonists-rusfertide-hits-phase-iii-goals-in-rare-leukemia Polycythemia vera illustration Moderna’s Mresvia approved as first mRNA-based RSV vaccine http://www.bioworld.com/articles/709135 Fri, 31 May 2024 12:00:00 -0400 https://www.bioworld.com/articles/709135-modernas-mresvia-approved-as-first-mrna-based-rsv-vaccine Vaccine vial and syringe Glycomimetics wilts on missed acute myeloid leukemia phase III http://www.bioworld.com/articles/708331 Mon, 06 May 2024 12:00:00 -0400 https://www.bioworld.com/articles/708331-glycomimetics-wilts-on-missed-acute-myeloid-leukemia-phase-iii Acute myeloid leukemia Day One’s Ojemda approved in US for rare pediatric cancer http://www.bioworld.com/articles/707897 Tue, 23 Apr 2024 12:00:00 -0400 https://www.bioworld.com/articles/707897-day-ones-ojemda-approved-in-us-for-rare-pediatric-cancer China accepts Sperogenix NDA filed for rare muscle disorder drug http://www.bioworld.com/articles/707210 Tue, 02 Apr 2024 12:00:00 -0400 https://www.bioworld.com/articles/707210-china-accepts-sperogenix-nda-filed-for-rare-muscle-disorder-drug Doctor examining child's leg China accepts Sperogenix NDA filed for rare muscle disorder drug http://www.bioworld.com/articles/707098 Mon, 01 Apr 2024 12:00:00 -0400 https://www.bioworld.com/articles/707098-china-accepts-sperogenix-nda-filed-for-rare-muscle-disorder-drug Doctor examining child's leg Renovos wins breakthrough device designation for nanoclay gel http://www.bioworld.com/articles/703992 Thu, 04 Jan 2024 11:00:00 -0500 https://www.bioworld.com/articles/703992-renovos-wins-breakthrough-device-designation-for-nanoclay-gel Renovos Renovite gel and reliable fusion Renovos Renovite gel and reliable fusion. Credit: Renovos Viiv wins FDA approval for new late-line HIV drug http://www.bioworld.com/articles/436243 Mon, 06 Jul 2020 13:30:00 -0400 https://www.bioworld.com/articles/436243-viiv-wins-fda-approval-for-new-late-line-hiv-drug FDA Approved seal Oncosil wins CE mark, breakthrough designation for pancreatic cancer device http://www.bioworld.com/articles/434129 Wed, 01 Apr 2020 13:00:00 -0400 https://www.bioworld.com/articles/434129-oncosil-wins-ce-mark-breakthrough-designation-for-pancreatic-cancer-device 4-1-Oncosil-CEO-Kenny.png Daniel Kenny, CEO, Oncosil Medical Ltd. Cleveland Diagnostics snags breakthrough device designation for novel prostate cancer assay http://www.bioworld.com/articles/430365 Thu, 17 Oct 2019 00:00:00 -0400 https://www.bioworld.com/articles/430365-cleveland-diagnostics-snags-breakthrough-device-designation-for-novel-prostate-cancer-assay Medtronic scores breakthrough device designation for TAAA stent graft system http://www.bioworld.com/articles/430113 Wed, 09 Oct 2019 00:00:00 -0400 https://www.bioworld.com/articles/430113-medtronic-scores-breakthrough-device-designation-for-taaa-stent-graft-system Trump promises quicker Medicare coverage for breakthrough technologies http://www.bioworld.com/articles/430228 Fri, 04 Oct 2019 00:00:00 -0400 https://www.bioworld.com/articles/430228-trump-promises-quicker-medicare-coverage-for-breakthrough-technologies Gala Therapeutics gets breakthrough device designation for Rheox system http://www.bioworld.com/articles/430311 Tue, 17 Sep 2019 00:00:00 -0400 https://www.bioworld.com/articles/430311-gala-therapeutics-gets-breakthrough-device-designation-for-rheox-system