News by subject: FDA

Asklepios BioPharmaceutical, Inc. (AskBio), a wholly-owned and independently-operated subsidiary of Bayer AG, today announced that the FDA's approval of a new adeno-associated virus (AAV) gene therapy to treat adults with hemophilia B marks another...

Inspira Technologies OXY B.H.N. Ltd.   (the "Company" or "Inspira Technologies"), a groundbreaking respiratory support technology company, announced today that it has begun the manufacturing process for the ALICE CPB (Cardiopulmonary Bypass) device...

Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, today announced it has received an additional FDA approval for treatment of essential tremor using its Exablate Neuro platform....

NS Pharma, Inc. (NS Pharma; President, Tsugio Tanaka), a wholly owned subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; President, Toru Nakai), today announced that the U.S. FDA has granted Orphan Drug Designation to NS-018 (ilginatinib), an...

SURGLASSES announced today that Caduceus S AR Spine Navigation System has received 510(k) clearance from the U.S. Food and Drug Administration and is ready to launch its products into the US market in the first quarter of 2023. Caduceus S is an...

Empirical Spine, Inc., a medical device company creating a new class of spinal implant, recently completed the final step in the U.S. Food & Drug Administration (FDA) submission process for the LimiFlextm Dynamic Sagittal Tethertm (DST). The...

Accelerate Diagnostics, Inc. today announced that the Company has submitted a 510(k) application to the FDA for Gram-negative menu expansion and breakpoint updates for the Accelerate PhenoTest® BC kit. Included in the submission are additional...

Abbott today announced the U.S. Food and Drug Administration (FDA) approval of the company's...

Neurophth Therapeutics, Inc. ("Neurophth") today announced receiving the U.S. Food and Drug Administration (FDA) clearance of its investigational new drug (IND) application on the in-vivo gene replacement therapy NFS-02 (rAAV2-ND1), for the treatment...

Fresenius Medical Care North America's (FMCNA) Renal Therapies Group, a leading provider of products and services for people with chronic kidney failure, announced that the U.S. Food and Drug Administration (FDA) has cleared the 2008 Series...

TG ImmunoPharma Co., Ltd. (Hefei, China), an innovative biotech company dedicated to the discovery of novel immunotherapeutic drugs and a leader in NK cell research globally, today announced that the U.S. Food and Drug Administration (FDA) has...

TG ImmunoPharma Co., Ltd. (Hefei, China), an innovative biotech company dedicated to the discovery of novel immunotherapeutic drugs and a leader in NK cell research globally, today announced that the U.S. Food and Drug Administration (FDA) has...

Today, the U.S. Food and Drug Administration approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating (cannot multiply in human cells) adenoviral vector?based gene therapy indicated for the treatment of adult patients with high-risk...

Medical device maker CEFALY Technology today unveiled the newest evolution of its FDA-cleared migraine treatment device: the CEFALY Connected. Representing a huge leap forward in drug-free migraine treatment technology, the Bluetooth-enabled CEFALY...

Kintara Therapeutics, Inc. ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug...

Providence Medical Technology, Inc., a medical device innovator focused on improving surgical outcomes for high-risk spine surgery patients, announced that the U.S. Food and Drug Administration (FDA) has cleared its CAVUX® Facet Fixation System (FFS)...

Capstone Development Services Company LLC ("Capstone") announced today that it has received approval from the U.S. Food and Drug Administration (FDA), as well as authorization from the European Commission for doxorubicin hydrocholoride liposomal...

Arthex Biotech S.A., a pre-clinical-stage biotechnology company pioneering innovative microRNA modulating approaches to diseases with high unmet medical needs, today announced that it has met key regulatory milestones in its program to develop ATX-01...

Mérieux NutriSciences Gainesville Laboratory receives official A2LA Accreditation Scope Expansion to include FDA Laboratory Accreditation for Analyses of Foods (LAAF)....

Denti.AI Auto-Chart, an AI-powered software developed by Denti.AI, has become the first and currently only dental auto-charting product cleared by the FDA. The device can assist dental professionals in the interpretation of intraoral and extraoral 2D...

Mirati Therapeutics, Inc. , a targeted oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for KRAZATItm (adagrasib), a targeted treatment option for adult patients with KRASG12C-mutated...

RF Medical Co., Ltd. is a premier Korean-based medical company serving the healthcare industry for almost two decades. Recently, FDA cleared RF Medical's patented MYGENtm M-3004 generator and MYOBLATEtm radiofrequency ablation system. Radiofrequency...

Evergreen Theragnostics has submitted a New Drug Application (NDA) for EVG-001 (Kit for preparation of Gallium-68 DOTATOC Injection), a radiopharmaceutical for imaging of neuroendocrine tumors using Positron Emission Tomography (PET), to the U.S....

BrainStorm Cell Therapeutics Inc. , a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the company has submitted a Type A Meeting Request to the U.S. Food and Drug Administration (FDA) to discuss...

IRRAS received US FDA 510(k) clearance for its class II next-generation IRRAflow control unit that enhances the procedural workflow for health care professionals treating critically ill patients suffering from intracranial bleeds.The cleared...

Braeburn announces that the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release weekly and monthly injections for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was accepted by the U.S. Food and Drug...

CORD, LLC, a privately held ophthalmic medical device company, announced today that it has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the Model SC9 Intraocular Lens (IOL) for the treatment of...

ARS Pharmaceuticals, Inc., announced that the U.S. Food & Drug Administration (FDA) has accepted its New Drug Application (NDA) for neffy (previously referred to as ARS-1), for the emergency treatment of severe type I allergic reactions in children...

AppliedVR, an immersive therapeutics (ITx) pioneer advancing a novel, virtual reality-based approach to medicine, today announced a contract with the U.S. Department of Veterans Affairs (VA) to provide its FDA-authorized RelieVRx (formerly EaseVRx)...

LB-P8, a novel drug being developed by LISCure Biosciences, Inc. (LISCure) as a treatment for Primary Sclerosing Cholangitis (PSC), has been designated as an orphan drug by the US FDA. On December 1, 2022, the US FDA notified LISCure of the orphan...

Visiox Pharma, LLC., a privately funded biopharmaceutical company focused on the development and commercialization of ophthalmic drugs to address highly prevalent diseases in need of new treatment options, today announced that it has received...

Avenda Health, an AI healthcare company creating the future of personalized prostate cancer care, today announced its cancer management platform, iQuestTM, has received 510(k) clearance by the U.S. Food and Drug Administration (FDA). iQuest combines...

Moleculin Biotech, Inc., ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the U.S. Food and Drug Administration...

Docosahexaenoic acid (DHA) is a member of the n-3 long-chain polyunsaturated fatty acid family, which is commonly found in deep-sea fish (such as tuna) and originates from Marine microalgae (such as Schizochytrium sp.). DHA, commonly known as brain...

Sionna Therapeutics, a life sciences company dedicated to developing highly effective and differentiated treatments for cystic fibrosis (CF), today announced the clearance of its Investigational New Drug application (IND) from the U.S. Food and Drug...

ABK Biomedical, Inc., an innovative medical device company dedicated to the research, development, and commercialization of advanced imageable embolic therapies, today announced an oversubscribed USD 30 million Series C financing. The round is co-led...

Ultromics' EchoGo® Heart Failure, an AI solution for echocardiography with the potential to revolutionize the diagnosis of heart failure with preserved ejection fraction (HFpEF), has received US Food and Drug Administration (FDA) clearance. The news...

ChroniSense Medical Ltd. took a step towards its vision of transforming chronic care management with Polsotm, the company's Remote Patient Monitoring (RPM) solution, achieving 510(k) clearance from the U.S. Food and Drug Administration (FDA). ...

Imagen Technologies, Inc. announced the U.S. Food and Drug Administration's 510(k) clearance of the computer-assisted detection (CADe) device Aorta-CAD. This new, FDA cleared device is designed to assist physicians at detecting findings on chest...

Deep Blue Medical Advances announced today it has received an additional 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its T-Line® Hernia Mesh for the sublay technique in open hernia surgery. This significantly expands the...

apoQlar, a German medical technology company, today announced it has received FDA 510(k) Class II clearance for VSI HoloMedicine®, a pioneering mixed reality software device enabling surgeons to plan complex procedures using the power of immersive 3D...

Protalix BioTherapeutics, Inc. , a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell based protein expression system, and...

IDEAYA Biosciences, Inc. , a synthetic lethality focused precision medicine...

Rigel Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved...

Oncolytics Biotech® Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents...

USA News Group  -  A series of new Fast Track designations have been handed out by the United States Food and Drug Administration (FDA) this week, causing a flurry of activity in the markets for the worthy recipients. The most recent to gain such a...

Oncolytics Biotech® Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents...

CorDx, a global leader in the development, manufacturing, and distribution of diagnostics and other medical devices, recently received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 Ag Test...

Oncolytics Biotech® Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents...

Citius Pharmaceuticals, Inc. ("Citius" or the "Company") , a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the U.S. Food and Drug Administration (FDA) has accepted the...