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https://www.prnewswire.com/news-releases/acepodia-announces-fda-clearance-of-investigational-new-drug-application-for-ace1831-in-igg4-related-disease-302306506.html Acepodia Announces FDA Clearance of Investigational New Drug Application for ACE1831 in... Nov 15, 2024 - /PRNewswire/ -- Acepodia (6976:TT), a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation... announces fda clearance investigational new acepodia drug application https://www.multivu.com/axsome_therapeutics/9389351-en-fda-approval-auvelity-alzheimers-agitation Axsome Therapeutics Announces FDA Approval of AUVELITY® (dextromethorphan HBr and bupropion HCl)... AUVELITY is a first-in-class treatment, which targets the NMDA and sigma-1 receptors, approved for agitation associated with dementia due to Alzheimer’s disease therapeutics announces fda approval axsome hbr bupropion https://www.prnewswire.com/news-releases/acepodia-announces-fda-clearance-of-investigational-new-drug-application-for-ace2016-a-first-in-class-allogeneic-anti-egfr-cell-therapy-302052466.html Acepodia Announces FDA Clearance of Investigational New Drug Application for ACE2016, a... Feb 4, 2024 - /PRNewswire/ -- Acepodia (6976:TT), a clinical stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation... announces fda clearance investigational new acepodia drug application https://www.globenewswire.com/news-release/2025/10/14/3166144/0/en/Tr1X-Announces-FDA-Clearance-of-IND-Application-for-TRX319-a-First-in-Class-Allogeneic-CAR-Tr1-Treg-Cell-Therapy-for-Progressive-Multiple-Sclerosis-and-50-Million-in-Additional-Fin.html Tr1X Announces FDA Clearance of IND Application for TRX319, Oct 14, 2025 - Tr1X announced the FDA has cleared its IND application for TRX319 in progressive multiple sclerosis and a $50M financing that extends its runway into... announces fda clearance ind application https://www.3dsystems.com/press-releases/3d-systems-announces-fda-510k-clearance-expanding-vspr-orthopedics-indications 3D Systems Announces FDA 510(k) Clearance Expanding VSP® Orthopedics Indications to Include... systems announces fda clearance expanding orthopedics https://www.neurologica.com/publications/press-releases/neurologica-announces-fda-510k-clearance-of-bodytom-64 NeuroLogica Announces FDA 510(k) Clearance of BodyTom® 64 Aug 9, 2023 - NeuroLogica announced that the BodyTom® 64 Point-of-Care Mobile Computed Tomography (CT) Scanner, has received 510(k) clearance from the U.S. FDA. announces fda clearance https://www.pharmiweb.com/press-release/2026-05-04/satellite-bio-announces-fda-rare-pediatric-disease-designation-for-sb-101-for-the-treatment-of-urea Satellite Bio Announces FDA Rare Pediatric Disease Designation for SB-101 for the Treatment of Urea... May 4, 2026 - First-in-class off-the-shelf liver therapy intended to restore metabolic liver function and help protect the developing brainUCDs are devastating,... announces fda satellite bio rare pediatric https://orcabio.com/orca-bio-announces-fda-review-extension-of-bla-for-orca-t-for-the-treatment-of-hematologic-malignancies/ Orca Bio Announces FDA Review Extension of BLA for Orca-T for the Treatment of Hematologic... Apr 28, 2026 - Our CompanyAbout UsLeadershipOrca Bio TimelineOur ApproachHigh-Precision TechnologyManufacturingOur PipelineOrca-TOrca-QScientific PublicationsExpanded Access... orca bio announces fda review extension bla https://www.prnewswire.com/news-releases/acepodia-announces-fda-clearance-of-ind-application-for-ace1831-an-anti-cd20-armed-allogeneic-gamma-delta-t-cell-therapy-candidate-to-treat-patients-with-non-hodgkins-lymphoma-301570711.html Acepodia Announces FDA Clearance of IND Application for ACE1831, an Anti-CD20 Armed Allogeneic... Jun 20, 2022 - /PRNewswire/ -- Acepodia, a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC)... announces fda clearance acepodia ind application anti https://nethertonnow.com/2026/03/11/quoin-pharmaceuticals-announces-fda-grants-fast-track-designation-for-qrx003-for-the-treatment-of-netherton-syndrome/ Quoin Pharmaceuticals Announces FDA Grants Fast Track Designation for QRX003 for the Treatment of... Mar 17, 2026 - — Fast Track Designation facilitates development and expedites regulatory review of therapies addressing serious conditions with significant unmet medical need... announces fda fast track pharmaceuticals grants designation https://www.prnewswire.com/news-releases/tr1x-announces-fda-clearance-of-first-investigational-new-drug-application-for-trx103-an-allogeneic-regulatory-t-cell-therapy-to-treat-autoimmune-diseases-302112587.html Tr1X Announces FDA Clearance of First Investigational New Drug Application for TRX103, an... Apr 10, 2024 - /PRNewswire/ -- Tr1X, Inc., an autoimmune and inflammatory disease cell therapy company focused on the development of novel allogeneic regulatory T cell... announces fda clearance investigational new first drug application https://www.azcentral.com/story/money/food/2026/05/06/horizon-organic-milk-recalled-fda-class-ii/89970313007/ FDA announces recall of Horizon Organic milk boxes across US fda announces organic milk recall horizon boxes https://www.kgun9.com/business/fda-announces-its-first-ok-of-fruit-flavored-e-cigarettes-for-adults-in-major-shift-under-trump FDA announces its first OK of fruit-flavored e-cigarettes for adults May 6, 2026 - U.S. health regulators have announced their first authorization of fruit-flavored electronic cigarettes intended for adult smokers. fda announces fruit flavored first ok cigarettes https://www.medtechdive.com/press-release/20260401-prana-surgical-announces-the-prana-systemtm-receives-fda-clearance-1/ Prana Surgical Announces the Prana System™ Receives FDA Clearance | MedTech Dive MedTech industry news receives fda clearance prana surgical announces medtech https://www.ktvh.com/business/fda-announces-its-first-ok-of-fruit-flavored-e-cigarettes-for-adults-in-major-shift-under-trump FDA announces its first OK of fruit-flavored e-cigarettes for adults May 6, 2026 - U.S. health regulators have announced their first authorization of fruit-flavored electronic cigarettes intended for adult smokers. fda announces fruit flavored first ok cigarettes https://www.democratandchronicle.com/story/money/food/2026/05/06/horizon-organic-milk-recalled-fda-class-ii/89970313007/ FDA announces recall of Horizon Organic milk boxes across US fda announces organic milk recall horizon boxes https://www.ky3.com/2026/05/06/fda-announces-first-ok-fruit-flavored-e-cigarettes-adults-major-shift-under-trump/ FDA announces first OK of fruit-flavored e-cigarettes for adults in major shift under Trump May 6, 2026 - As a presidential candidate, Donald Trump promised to save the vaping industry. fda announces fruit flavored major shift first ok https://www.jacksonville.com/story/money/food/2026/05/06/horizon-organic-milk-recalled-fda-class-ii/89970313007/ FDA announces recall of Horizon Organic milk boxes across US fda announces organic milk recall horizon boxes https://www.medtechdive.com/news/fda-announces-warfarin-test-strips-iv-fluid-transfer-systems-recalls/547518/ FDA announces warfarin test strips, IV fluid transfer systems recalls | MedTech Dive The agency identified separate Class I recalls addressing malfunctions in certain Roche Diagnostics test strips and Vial2Bag fluid transfer systems made by... fda announces test strips fluid transfer iv systems https://www.kxlf.com/business/fda-announces-its-first-ok-of-fruit-flavored-e-cigarettes-for-adults-in-major-shift-under-trump FDA announces its first OK of fruit-flavored e-cigarettes for adults May 6, 2026 - U.S. health regulators have announced their first authorization of fruit-flavored electronic cigarettes intended for adult smokers. fda announces fruit flavored first ok cigarettes https://www.turnto23.com/business/fda-announces-its-first-ok-of-fruit-flavored-e-cigarettes-for-adults-in-major-shift-under-trump FDA announces its first OK of fruit-flavored e-cigarettes for adults May 6, 2026 - U.S. health regulators have announced their first authorization of fruit-flavored electronic cigarettes intended for adult smokers. fda announces fruit flavored first ok cigarettes https://www.thenewsherald.com/2026/05/05/fda-vapes-flavors/ FDA announces its first OK of fruit-flavored e-cigarettes for adults in major shift under Trump May 5, 2026 - The new e-cigarettes authorized Tuesday come in mango, blueberry and two varieties of menthol. fda announces fruit flavored major shift first ok https://www.bioqubeventures.com/bicara-therapeutics-announces-ficerafusp-alfa-granted-breakthrough-therapy-designation-by-u-s-fda-for-1l-hpv-negative-r-m-hnscc/ Bicara Therapeutics Announces Ficerafusp Alfa Granted Breakthrough Therapy Designation by U.S. FDA... Dec 1, 2025 - Designation supported by results from multiple dose cohorts from the Phase 1/1b trial of ficerafusp alfa in 1L HPV-negative R/M HNSCC BOSTON, Oct. 13, 2025... therapeutics announces bicara alfa granted breakthrough https://www.oklahoman.com/story/money/food/2026/05/06/horizon-organic-milk-recalled-fda-class-ii/89970313007/ FDA announces recall of Horizon Organic milk boxes across US fda announces organic milk recall horizon boxes https://www.ydr.com/story/money/food/2026/05/06/horizon-organic-milk-recalled-fda-class-ii/89970313007/ FDA announces recall of Horizon Organic milk boxes across US fda announces organic milk recall horizon boxes https://www.fda.gov/news-events/press-announcements/fda-announces-major-steps-implement-real-time-clinical-trials FDA Announces Major Steps to Implement Real-Time Clinical Trials | FDA The U.S. Food and Drug Administration today announced two major steps as part of an initiative to advance the implementation of real-time clinical trials... fda announces real time major steps implement https://www.desmoinesregister.com/story/money/food/2026/05/06/horizon-organic-milk-recalled-fda-class-ii/89970313007/ FDA announces recall of Horizon Organic milk boxes across US fda announces organic milk recall horizon boxes https://www.lex18.com/business/fda-announces-its-first-ok-of-fruit-flavored-e-cigarettes-for-adults-in-major-shift-under-trump FDA announces its first OK of fruit-flavored e-cigarettes for adults May 6, 2026 - U.S. health regulators have announced their first authorization of fruit-flavored electronic cigarettes intended for adult smokers. fda announces fruit flavored first ok cigarettes https://www.mypatriotsupply.com/blogs/headlines-that-matter/fda-announces-recall-on-9-popular-potato-chips-for-potential-salmonella-contamination FDA Announces Recall on 9 Popular Potato Chips for Potential Salmonell - Scout May 5, 2026 - Nine popular potato chip products were recalled nationwide over possible salmonella contamination tied to a seasoning ingredient. fda announces potato chips recall popular potential https://apnews.com/article/ecigarettes-fda-flavors-vaping-fruit-trump-ff2701ce00d797194666917beca43de6 FDA announces its first OK of fruit-flavored e-cigarettes for adults | AP News May 5, 2026 - U.S. health regulators have announced their first authorization of fruit-flavored electronic cigarettes intended for adult smokers. fda announces fruit flavored first ok cigarettes https://www.medtechdive.com/news/fda-announces-fiscal-2020-device-user-fee-rates/559903/ FDA announces fiscal 2020 device user fee rates | MedTech Dive The fees, which cover medical device registration, submissions and certain periodic reports, show slight increases from the 2019 rates. fda announces fiscal device user fee https://www.tv20detroit.com/business/fda-announces-its-first-ok-of-fruit-flavored-e-cigarettes-for-adults-in-major-shift-under-trump FDA announces its first OK of fruit-flavored e-cigarettes for adults May 6, 2026 - U.S. health regulators have announced their first authorization of fruit-flavored electronic cigarettes intended for adult smokers. fda announces fruit flavored first ok cigarettes https://www.kbtx.com/2026/05/06/fda-announces-first-ok-fruit-flavored-e-cigarettes-adults-major-shift-under-trump/ FDA announces first OK of fruit-flavored e-cigarettes for adults in major shift under Trump May 6, 2026 - As a presidential candidate, Donald Trump promised to save the vaping industry. fda announces fruit flavored major shift first ok