News by subject: FDA

Heron Therapeutics, Inc. , a commercial-stage biotechnology company focused on improving the lives of patients by...

Hoth Therapeutics, Inc. , a patient-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted an Investigational New Drug (IND) application for the company's HT-001 therapeutic for the treatment...

Movano Health , a purpose-driven healthcare solutions company at the intersection of medical and consumer devices, today announces its smart ring, Evie. Designed specifically for women, Evie is sleek, intelligent, and comfortable, providing users...

ZielBio, Inc., a clinical-stage biotechnology company discovering new treatments for cancer and other serious diseases through its innovative drug discovery platform, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan...

MindRank, an artificial intelligence (AI)-empowered drug discovery company, announces today that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for MDR-001, an oral small-molecule...

In a significant step for the advancement of human health, Congress passed the FDA Modernization Act as part of the FY2023 Omnibus Appropriations Bill. It is now being forward to President Biden's desk to be signed into law....

Today, Overhearing.com announced immediate availability of over-the-counter hearing aids, enabling Americans to alleviate mild to moderate hearing loss without the need for a prescription....

Today, the U.S. Food and Drug Administration approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with human immunodeficiency virus type 1 (HIV-1), whose HIV infections cannot be successfully treated with...

Actinogen Medical Limited  is pleased to announce receipt today of agreement from the US Food and Drug Administration (FDA) to proceed with its six-month, Phase 2b, placebo-controlled clinical trial of Xanamem in patients with early stages of...

IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products,, today announced that the Investigational New Drug (IND) application...

Everest Medicines (HKEX 1952.HK) announced today that its licensing partner, Pfizer Inc. has received acceptance from the U.S. Food and Drug Administration (FDA) for review a New Drug Application (NDA) for etrasimod for individuals living with...

Bantam Vape, LLC, a provider of high-quality, science-based e-liquid products, announced today the acceptance of its Premarket Tobacco Product Application (PMTA) submission by the U.S. Food and Drug Administration for its non-tobacco nicotine...

Radius Health, Inc. ("Radius" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has approved TYMLOS® (abaloparatide), a parathyroid hormone related peptide [PTHrP(1?34)] analog, as a treatment to increase bone density...

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...