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https://www.techtarget.com/pharmalifesciences/news/366607817/FDA-Granted-SirPlux-Duo-Drug-Coated-Balloon-Breakthrough-Designation FDA Granted SirPlux Duo Drug-Coated Balloon Breakthrough Designation | TechTarget In a recent press release, NanoTherapies announced that the FDA granted its SirPlux Duo Drug-Coated Balloon, used to treat coronary artery disease,... fda granted duo drug coated balloon https://finviz.com/news/341198/caribou-biosciences-announces-the-fda-granted-regenerative-medicine-advanced-therapy-rmat-designation-to-cb-011-an-allogeneic-anti-bcma-car-t-cell-therapy Caribou Biosciences Announces the FDA Granted Regenerative Medicine Advanced Therapy (RMAT)... Stock screener for investors and traders, financial visualizations. caribou biosciences fda granted regenerative medicine advanced therapy announces https://investingnews.com/daily/life-science-investing/biotech-investing/calithera-biosciences-announces-fda-fast-track-designation-granted-cb-839/ Calithera Biosciences Announces FDA Fast Track Designation Granted to CB-839 | INN Jan 5, 2026 - Calithera Biosciences (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, today announced that the... fda fast track https://refractor.io/psychedelics/psychedelic-psilocybin-therapy-for-depression-granted-breakthrough-therapy-status-by-fda/ Psychedelic psilocybin therapy for depression granted Breakthrough Therapy status by FDA Sep 20, 2024 - The FDA has given psilocybin therapy for treatment-resistant depression a Breakthrough Therapy status. This classification suggests the treatment has... therapy for depression breakthrough status psychedelic psilocybin granted https://www.biospace.com/avidity-biosciences-granted-fda-fast-track-designation-for-aoc-1044-for-treatment-of-duchenne-muscular-dystrophy-mutations-amenable-to-exon-44-skipping Avidity Biosciences Granted FDA Fast Track Designation for AOC 1044 for Treatment of Duchenne... Apr 24, 2023 - Avidity Biosciences, Inc. (Nasdaq: RNA) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AOC 1044 for the... fda fast track https://www.fda.gov/drugs/development-resources/products-granted-partial-waiver-because-inability-develop-pediatric-formulation Products Granted a Partial Waiver Because of the Inability to Develop a Pediatric Formulation | FDA Products Granted a Partial Waiver Because of the Inability to Develop a Pediatric Formulation https://www.takeda.com/newsroom/newsreleases/2020/takeda-announces-us-fda-breakthrough-therapy-designation-granted-for-pevonedistat-for-the-treatment-of-patients-with-higher-risk-myelodysplastic-syndromes-hr-mds/ Takeda Announces U.S. FDA Breakthrough Therapy Designation Granted for Pevonedistat for the... Takeda Announces U.S. FDA Breakthrough Therapy Designation Granted for Pevonedistat for the Treatment of Patients with Higher-Risk Myelodysplastic Syndromes... u s fda breakthrough therapy https://www.tomsguide.com/audio/airpods/airpods-pro-2-just-granted-fda-authorization-for-hearing-aid-use Apple AirPods Pro 2 just granted FDA authorization for hearing aid use | Tom's Guide Sep 12, 2024 - The FDA has given authorization for Apple's AirPods Pro 2 to be used as an over-the-counter hearing aid, which is exciting news. https://www.businesswire.com/news/home/20251218127420/en/BeOne-Medicines-Granted-U.S.-FDA-Fast-Track-Designation-for-BGB-B2033-as-Treatment-for-Hepatocellular-Carcinoma BeOne Medicines Granted U.S. FDA Fast Track Designation for BGB-B2033 as Treatment for... BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has... https://www.newswire.com/news/billiontoone-granted-fda-emergency-use-authorization-for-21205657 BillionToOne Granted FDA Emergency Use Authorization for Groundbreaking RNA Extraction-Free... BillionToOne's unique testing protocol removes costly, time-consuming step of RNA extraction and significantly expands testing capacity emergency use authorization rna extraction granted fda https://www.gsk.com/en-gb/media/press-releases/benlysta-granted-orphan-drug-designation-by-us-fda-for-the-potential-treatment-of-systemic-sclerosis/ Benlysta granted Orphan Drug Designation by US FDA for the potential treatment of systemic... GSK plans to initiate a phase II/III trial for systemic sclerosis associated interstitial lung disease (SSc-ILD) in the first half of 2023. https://finviz.com/news/254966/palvella-therapeutics-granted-fda-fast-track-designation-for-qtorin-39-rapamycin-anhydrous-gel-qtorin-rapamycin-for-the-treatment-of-angiokeratomas Palvella Therapeutics Granted FDA Fast Track Designation for QTORIN 3.9% Rapamycin Anhydrous Gel... Stock screener for investors and traders, financial visualizations. https://www.biospace.com/press-releases/agios-announces-fda-orphan-drug-designation-granted-to-tebapivat-ag-946-for-treatment-of-myelodysplastic-syndromes-mds Agios Announces FDA Orphan Drug Designation Granted to Tebapivat (AG-946) for Treatment of... https://www.businesswire.com/news/home/20200609005042/en/GTX-medical-Granted-FDA-Breakthrough-Device-Designation-for-Go-2-Targeted-Epidural-Spinal-Stimulation-TESS-System GTX medical Granted FDA Breakthrough Device Designation for Go-2 Targeted Epidural Spinal... GTX medical (GTX), today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its implantable Go-2 system... fda breakthrough device https://reurl.cc/EV4VE0 Click Therapeutics granted FDA market authorization for digital migraine drug Data from the clinical trial might give patients a new option for treating migraines. market authorization therapeutics granted fda digital https://www.medicaldaily.com/teva-granted-exclusive-marketing-rights-plan-b-pill-fda-will-prices-soar-247962 Teva Granted Exclusive Marketing Rights For Plan B Pill By FDA; Will Prices Soar? Jul 24, 2013 - The FDA has granted Teva Pharmaceuticals three years of exclusive marketing rights to the Plan B contraceptive. https://www.biospace.com/agios-announces-fda-orphan-drug-designation-granted-to-mitapivat-for-treatment-of-sickle-cell-disease Agios Announces FDA Orphan Drug Designation Granted to Mitapivat for Treatment of Sickle Cell... Nov 13, 2020 - Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that the... https://www.biospace.com/eiger-announces-breakthrough-therapy-designation-granted-by-fda-for-avexitide-for-treatment-of-post-bariatric-hypoglycemia-pbh Eiger Announces Breakthrough Therapy Designation Granted by FDA for Avexitide for Treatment of... Jun 17, 2019 - Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare and ultra-rare diseases, today... breakthrough therapy https://www.pfizer.com/news/press-release/press-release-detail/pfizer-granted-fda-breakthrough-therapy-designation Pfizer Granted FDA Breakthrough Therapy Designation for Respiratory Syncytial Virus (RSV) Vaccine... Pfizer Inc. (NYSE:PFE) today announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06482077 or RSVpreF, received Breakthrough Therapy... respiratory syncytial virus breakthrough therapy https://www.biospace.com/snoo-is-granted-fda-de-novo-approval-for-keeping-sleeping-babies-safely-positioned-on-the-back SNOO is Granted FDA De Novo Approval For Keeping Sleeping Babies Safely Positioned on the Back -... Apr 3, 2023 - Marking a significant advance in infant safety, the U.S. Food and Drug Administration (FDA) has given De Novo approval to Happiest Baby's SNOO Smart Sleeper. https://www.biospace.com/plus-therapeutics-granted-u-s-fda-orphan-drug-designation-to-rhenium-186re-obisbemeda-for-the-treatment-of-breast-cancer-with-leptomeningeal-metastases Plus Therapeutics Granted U.S. FDA Orphan Drug Designation to Rhenium (186Re) Obisbemeda for the... Nov 6, 2023 - Plus Therapeutics, Inc. announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to rhenium obisbemeda for the treatment of... https://www.biospace.com/viracta-therapeutics-announces-orphan-drug-designation-granted-by-the-u-s-fda-to-nana-val-for-the-treatment-of-nasopharyngeal-carcinoma Viracta Therapeutics Announces Orphan Drug Designation Granted by the U.S. FDA to Nana-val for the... Dec 12, 2023 - Viracta Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation to Nana-val (nanatinostat in... https://www.businesswire.com/news/home/20200928005213/en/Hologic-Granted-FDA-Emergency-Use-Authorization-for-Asymptomatic-COVID-19-Testing-with-Panther-Fusion-SARS-CoV-2-Assay Hologic Granted FDA Emergency Use Authorization for Asymptomatic COVID-19 Testing with Panther... Hologic Granted FDA Emergency Use Authorization for Asymptomatic COVID-19 Testing with Panther Fusion SARS-CoV-2 Assay emergency use authorization https://www.roche.com/investors/updates/inv-update-2022-07-19 Roche's Elecsys Amyloid Plasma Panel granted FDA Breakthrough Device Designation to enable a timely... The Elecsys Amyloid Plasma Panel is intended to be used in conjunction with other clinical information in symptomatic patients who are being evaluated for... https://www.biospace.com/23andme-granted-authorization-by-fda-to-market-first-direct-to-consumer-genetic-test-under-regulatory-pathway-for-novel-devices 23andMe Granted Authorization By FDA To Market First Direct-To-Consumer Genetic Test Under... https://www.prnewswire.com/news-releases/janssen-announces-us-fda-breakthrough-therapy-designation-granted-for-niraparib-for-the-treatment-of-metastatic-castration-resistant-prostate-cancer-300930955.html Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Niraparib for the Treatment... u s fda https://www.prlog.org/12658126-curtana-pharmaceuticals-granted-fda-orphan-drug-designation-for-ct-179-for-the-treatment-of-gliomas.html Curtana Pharmaceuticals Granted FDA Orphan Drug Designation for CT-179 for the Treatment of Gliomas... Curtana Pharmaceuticals Granted FDA Orphan Drug Designation for CT-179 for the Treatment of Gliomas. Curtana Pharmaceuticals, a privately-held, preclinical... https://www.news-medical.net/news/20090831/Doxorubicin-granted-orphan-drug-designation-by-the-FDA.aspx Doxorubicin granted orphan drug designation by the FDA Jun 24, 2019 - Delcath Systems, Inc., a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced that... orphan drug designation by the doxorubicin granted fda https://www.globenewswire.com/fr/news-release/2025/04/29/3070088/0/en/incyclix-bio-granted-u-s-fda-fast-track-designation-for-inx-315-to-treat-ccne1-amplified-platinum-resistant-refractory-ovarian-cancer.html Incyclix Bio Granted U.S. FDA Fast Track Designation for Fast Track designation highlights potential of INX-315 to address unmet need for patients with recurrent advanced/metastatic cancer... u s fda fast track designation bio granted https://www.biospace.com/sierra-announces-momelotinib-granted-fda-fast-track-designation Sierra Announces Momelotinib Granted FDA Fast Track Designation - BioSpace Jun 6, 2019 - Sierra Oncology, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to momelotinib, a JAK1, JAK2 and ACVR1... fda fast track sierra announces momelotinib granted https://www.globenewswire.com/news-release/2025/04/15/3061608/0/en/Atsena-Therapeutics-Granted-U-S-FDA-Regenerative-Medicine-Advanced-Therapy-Designation-for-ATSN-201-Gene-Therapy-to-Treat-X-linked-Retinoschisis.html Atsena Therapeutics Granted U.S. FDA Regenerative Medicine Marks fourth FDA designation for ATSN-201, which has also received Fast Track, Rare Pediatric Disease and Orphan Drug Designations... u s fda therapeutics granted regenerative medicine https://www.biospace.com/press-releases/cero-therapeutics-holdings-inc-announces-fda-orphan-drug-designation-granted-to-cer-1236-for-the-treatment-of-acute-myeloid-leukemia-aml CERo Therapeutics Holdings, Inc. Announces FDA Orphan Drug Designation Granted to CER-1236 for the... https://menafn.com/1111057828/MRM-Healths-Lead-Candidate-MH002-Granted-Fast-Track-Designation-By-US-FDA-For-The-Treatment-Of-Mild-To-Moderate-Ulcer MRM Health's Lead Candidate MH002 Granted Fast Track Designation By U.S. FDA For The Treatment Of... MRM Health's Lead Candidate MH002 Granted Fast Track Designation By U.S. FDA For The Treatment Of Mild-To-Moderate Ulcer....(BUSINESS WIRE )--MRM Health, a... https://www.sanofi.com/en/media-room/press-releases/2020/2020-11-18-06-15-00-2128828 Press Release: Rilzabrutinib granted FDA Fast Track Designation for treatment of immune... Rilzabrutinib granted FDA Fast Track... fda fast track press release https://www.prnewswire.co.uk/news-releases/fda-has-granted-innocan-pharma-a-meeting-date-for-lpt-cbd-for-chronic-pain-302151667.html FDA Has Granted Innocan Pharma a Meeting Date for LPT-CBD for Chronic Pain /PRNewswire/ -- Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (OTCQB: INNPF) ("Innocan" or the "Company"), is pleased to announce significant... https://www.globenewswire.com/de/news-release/2025/04/29/3070088/0/en/incyclix-bio-granted-u-s-fda-fast-track-designation-for-inx-315-to-treat-ccne1-amplified-platinum-resistant-refractory-ovarian-cancer.html Incyclix Bio Granted U.S. FDA Fast Track Designation for Fast Track designation highlights potential of INX-315 to address unmet need for patients with recurrent advanced/metastatic cancer... u s fda fast track designation bio granted https://refractor.io/psychedelics/psilocybin-major-depression-mdd-usona-breakthrough-therapy-fda/ Psilocybin for major depression granted Breakthrough Therapy by FDA Sep 20, 2024 - The US Food and Drug Administration (FDA) has granted psilocybin therapy a Breakthrough Therapy designation for the second time in a year, this time with a... major depression breakthrough therapy psilocybin granted fda https://www.notebookcheck.net/FaceHeart-granted-FDA-clearance-for-Vitals-AI-software-that-measures-vital-signs-by-examining-remote-patient-videos.793243.0.html FaceHeart granted FDA clearance for Vitals AI software that measures vital signs by examining... The FDA has granted 510(k) clearance to FaceHeart Vitals AI software. This innovative application measures vital signs such as heart rate and blood pressure... https://www.prnewswire.com/il/news-releases/exero-medicals-smart-sensor-granted-fda-breakthrough-designation-301192665.html Exero Medical's Smart Sensor Granted FDA Breakthrough Designation /PRNewswire/ -- Exero Medical, developer of a wireless system for early detection of anastomotic leaks (AL) following gastrointestinal (GI) surgery, today... smart sensor exero medical granted fda https://www.biospace.com/press-releases/nipocalimab-the-first-and-only-investigational-treatment-to-be-granted-u-s-fda-breakthrough-therapy-designation-for-the-treatment-of-adults-with-moderate-to-severe-sjogrens-disease-has-now-received-fast-track-designation Nipocalimab, the first and only investigational treatment to be granted U.S. FDA Breakthrough... the first and only https://www.biospace.com/kyverna-therapeutics-granted-fda-fast-track-designation-for-kyv-101-in-the-treatment-of-patients-with-refractory-myasthenia-gravis Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101 in the Treatment of Patients... Dec 13, 2023 - Kyverna Therapeutics, Inc. (Kyverna) today announced it received fast track designation by the U.S. Food and Drug Administration (FDA) for its autologous,... https://www.businesswire.com/news/home/20260424121830/en/Compass-Pathways-Announces-FDA-Granted-NDA-Rolling-Review-Request-and-Awarded-Commissioners-National-Priority-Voucher Compass Pathways Announces FDA Granted NDA Rolling Review Request and Awarded Commissioner's... Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today an... https://www.biospace.com/lifewatch-corp-granted-fda-approval-for-its-mobile-cardiac-telemetry-1-lead-patch LifeWatch Corp Granted FDA Approval for its Mobile Cardiac Telemetry 1-Lead Patch - BioSpace https://www.jpost.com/health-science/aidoc-granted-fda-clearance-on-ai-that-flags-incidental-pulmonary-embolism-646552 Aidoc granted FDA clearance on AI that flags pulmonary embolism | The Jerusalem Post This is the company's 6th FDA clearance and the first clearance for triage of incidental pulmonary embolism.