News by subject: FDA

Ideal Medical Technologies (IMT), developer of FUSION, a fully autonomous closed loop artificial pancreas system designed for use in the ICU setting, announced today that the U.S. Food and Drug Administration (FDA) has approved the second phase of...

Baebies has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its rapid, point-of-care test for glucose-6-phosphate dehydrogenase (G6PD) deficiency. The test is run on the FINDER® platform, which features a toaster-sized...

W. L. Gore & Associates (Gore) announced today that it is initiating the RELIEF Clinical Study ? an investigational study to evaluate the safety and efficacy of...

Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and...

ProciseDx Inc. announces FDA clearance of its ProciseDx instrument and C reactive Protein (CRP) test. Procise CRP gives quantitative determination of CRP levels in patient serum in less than 5 minutes. ProciseDx expects FDA clearances of additional...

Evolution Optiks Limited, a global leader in light field technology applications, announced today the completion of enrollment of the pivotal U.S. Food and Drug Administration (FDA) clinical study to evaluate the safety and efficacy of its subjective...

Allotrope Medicaltm Inc., a company committed to advancing surgical efficiency and safety, announced that they have received Safer Technologies Program (STeP) designation from the FDA for their surgical device StimSite. For the past year, StimSite...

Brand Institute is proud to announce its work with scPharmaceuticals in developing the brand name FUROSCIX®, which was approved by the FDA on October 7, 2022....

Inhibikase Therapeutics, Inc. ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related disorders and other diseases of the...

Neurosteer Inc. today announced the FDA clearance of its Neurosteer® single-channel EEG brain monitoring platform. This clearance allows Neurosteer's unobtrusive multi-purpose system to be used in a broad range of clinical settings. In the ICU, it...

The National Industrial Hemp Council of America (NIHC) President and CEO Patrick Atagi sent a letter today to U.S. Food and Drug Administration Commissioner Robert Califf urging approval of hemp seed as an animal feed ingredient....

AlphaIDtm At Home, the company's first FDA clearance for direct-to-consumer use, enables U.S. adults to screen for their genetic risk of alpha1-antitrypsin deficiency (alpha-1) without prescription from a healthcare professionalA simple saliva sample...

Fresenius Medical Care North America's (FMCNA) Renal Therapies Group announced today that the U.S. Food and Drug Administration (FDA) has cleared the AquaAtm water system, one of the industry's most efficient water purification systems available for...

Creative Medical Technology Holdings, Inc. , an immuno-endocrine company working to revolutionize care through the development of potentially best-in-class regenerative therapeutics, today announced that the U.S. Food and Drug Administration has...

The a2 Milk Companytm announced it has received discretion from the U.S. Food and Drug Administration to supply its a2 Platinum® Premium infant milk formula to the U.S. market to help alleviate the ongoing supply crisis. a2 Platinum® is manufactured...

Eccogene announced that the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application to commence a Phase I trial of its glucagon-like peptide 1 receptor agonist (GLP-1 RA) ECC5004 for type 2 diabetes...

Codagenix Inc., a clinical-stage synthetic biology company with a rational virus design platform for viral vaccines and immuno-oncology therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation...

Cochlear Limited , the global leader in implantable hearing solutions, receives U.S. Food and Drug Administration (FDA) approval for the Cochleartm Nucleus® 8 Sound Processor. The Nucleus 8 Sound Processor is now the smallest and lightest...

Akorn Operating Company LLC, a specialty pharmaceutical company, is launching the first to market generic Cetrorelix Acetate for Injection 0.25 mg (Cetrorelix) at the 2022 American Society for Reproductive Medicine Conference (ASRM) Conference in...

Myeloid Therapeutics, Inc. ("Myeloid"), a clinical-stage mRNA-immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to MT-101 in patients with refractory or relapsed CD5+ peripheral...

Transit Scientific, a pioneer in developing medical devices to treat calcified cardiovascular disease, dilate stenosed intimal hyperplasia, and access, cross, & deliver to distal vessels, announced today the XO RX 2.2F and XO RX 3.8F Platform...

CorNeat Vision, an Israeli biomimetic implant and technology company, unveiled the EverMatrixtm, a revolutionary tissue-integrating material technology. The EverMatrixtm is the world's first nondegradable, 100% synthetic, biomimetic Extra Cellular...

The Perinatal Stem Cell Society has organized a workshop Nov. 3 in Fort Lauderdale, Fla. and streamed to unite the biologics industry and work with the FDA towards a patient-centered goal. "I called this one-day workshop so the industry can partner...

--ASC10 has two indications: monkeypox and SARS-CoV-2 virus infections. The Investigational New Drug (IND) application of the latter was approved by the U.S. Food and Drug Administration (FDA) in August 2022 and Phase Ib clinical trial in COVID-19...

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved TECVAYLItm (teclistamab-cqyv) for the treatment of adult patients with relapsed or refractory multiple myeloma, who...

COUR Pharmaceuticals, a clinical-stage biotechnology company developing novel immune-modifying nanoparticles designed to reprogram the immune system for the treatment of autoimmune disorders (COUR NanoParticles or CNPs), today announced that the U.S....

Cellevolve Bio, Inc. ("the Company" or "Cellevolve"), a clinical stage development...

NeuroOne Medical Technologies Corporation (NeuroOne or the Company), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that it has received U.S....

Rznomics Inc., a South Korea based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, recently received Phase 1/2a IND approval from the U.S FDA in October 10th for its hepatocellular carcinoma (HCC) treatment...

Nihon Medi-Physics Co., Ltd. (NMP), a leading radiopharmaceutical company in Japan, is pleased to announce that the U.S. Food and Drug Administration (FDA) has recently accepted NMP's Investigational New Drug (IND) application to initiate a...

CMP Pharma announced today that Tadliq® (Tadalafil) Oral Suspension, 20 mg/5 mL, the first and only FDA-approved oral liquid suspension of tadalafil, is now available. Tadliq is the first and only FDA-approved liquid oral suspension of tadalafil for...

Vapor Cartridge Technology LLC, based in historic Stillwater Minnesota, has invented, and patented a groundbreaking technology that portends the power to truly change the entire cannabis industry. Vapor Cartridge Technology LLC has invented and...

RINVOQ is now approved as the first and only oral JAK inhibitor for adults with active non-radiographic axial spondyloarthritis (nr-axSpA)RINVOQ is the first and only JAK inhibitor approved for both active ankylosing spondylitis (AS) and...

Lannett Company, Inc. today announced that it has received approval from the US Food and Drug Administration (FDA) to manufacture Numbrino®, the company's branded topical anesthetic product, at its main plant in Seymour, Indiana. The company...

Akeso, Inc. (9926. HK) ("Akeso"), a China-based biopharmaceutical company focusing on the development and commercialization of innovative therapeutic antibodies for Oncology & Immunology, announced that the Center for Drug Evaluation (CDE) of China...

Endymed Ltd , currently traded on the Tel Aviv Stock Exchange, is proud to announce that it has been granted FDA approval for the marketing and sales of Pure Laser, a new hair removal device in the United States. The Pure Laser was developed in the...

Today, Johnson & Johnson MedTech* announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson**, has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TELIGENtm System, an integrated technology platform...

Tris Pharma, Inc. (Tris) a fully integrated pharmaceutical company with a robust portfolio of CNS products announced today that DYANAVEL® XR (amphetamine) extended-release tablets, for oral use, CII and DYANAVEL® XR (amphetamine) extended-release...

Cordis, a worldwide leader in the development and manufacturing of interventional cardiovascular and endovascular technologies, today announced its acquisition, subject to customary closing conditions including regulatory approvals, of MedAlliance, a...

Vitti Labs, an AATB Accredited Tissue Bank focused on life science research, development, and manufacturing, announced today that the U.S. Food and Drug Administration (FDA) has approved their Investigational New Drug Application (IND) of EV-Pure, an...

Zhiyi Biotech announced that FDA has approved the Company's Investigational New Drug (IND) application to develop SK10 (Inactivated Bacteroides fragilis) for the treatment of Chemotherapy-induced Diarrhea (CID) . The approval of this IND authorizes...

Tampa General Hospital (TGH), in partnership with Florida Urology Partners, are the first in the U.S. to offer a next-generation technology that recently received U.S. Food and Drug Administration (FDA) 510(k) clearance....

Medtronic plc today announced it has received U.S. Food and Drug Administration (FDA) approval for expanded labeling of a cardiac lead that taps into the heart's natural electrical system, giving patients needed therapy while avoiding complications...

Lucid Hearing, LLC, a Fort Worth-based market leader and global provider of advanced hearing technology and audio solutions, is offering its over-the-counter hearing aids to consumers in more than 450 Sam's Club locations nationwide starting today....

Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on oncology, announced today that it has received clearance from the US Food and Drug Administration (FDA) to commence Phase I studies with PT217, its anti-Delta-like ligand...

ulrich medical USA, Inc., a privately held medical device company focused on developing and commercializing musculoskeletal implant technologies in the United States, today announced the FDA has given 510(k) clearance of its Flux-C 3D printed porous...

The Plastic Surgery Foundation (PSF) received approval from the U.S. Food and Drug...

QT Imaging, Inc., a medical imaging company focused on the development and clinical adoption of novel products for breast cancer imaging, today announced the award of a five-year National Cancer Institute grant to study the progress of neo-adjuvant...

RemeGen Co., Ltd. ("RemeGen" or "the Company") (9995.HK, SHA: 688331), a commercial-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) for its proprietary novel fusion...

BioMarin Pharmaceutical Inc. announced today that the U.S. Food and Drug Administration (FDA) accepted the Company's resubmission of the Biologics License Application (BLA) for its investigational AAV gene therapy, valoctocogene roxaparvovec, for...