News by subject: FDA

SafeSource Direct, LLC, the maker of high-quality, American-made personal protective equipment (PPE), announced today that its chemo-rated nitrile exam gloves have received FDA 510(k) clearance. The determination follows extensive testing and clears...

On June 13, 2022, Eli Lilly announced the FDA approval of Olumiant for severe alopecia areata (AA), making it the first systemic therapy available in the US to treat the disease. In July 2022, Spherix began tracking the launch of Olumiant as part of...

CULT Food Science Corp. ("CULT" or the "Company") (FRA: LN0), a food technology company pioneering the commercialization of cellular agriculture products and consumer brands, applauds the United States Food and Drug Administration for their...

After a rigorous evaluation, UPSIDE Foods became the first company in the world to receive a "No Questions" letter from the U.S. Food and Drug Administration (FDA) for cultivated meat, poultry, or seafoodThis letter indicates that the FDA accepts...

Argentum Medical, a medical device leader and pioneer of silver-plated dressing technology, announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Radiation Dermatitis (RD) and Cutaneous Radiation Injury...

AEYE Health, a leading company for AI-based retinal imaging and diagnostics, is pleased to announce that it received a 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market its diagnostic screening system for diabetic retinopathy....

NeuroSense Therapeutics Ltd. ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced the U.S. Food and Drug Administration (FDA) has cleared the...

Rockfield Medical Devices Limited, a commercial-stage medical device company focused on developing solutions to transform the mobility and quality of life of tube feeders, today announced U.S. Food and Drug Administration ("FDA") 510(k) clearance of...

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...

Tyber Medical LLC, the global, leading private-label medical device provider for major orthopedic trauma, extremity, and spine companies, has been awarded a U.S. Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shottm Staple...

Developed as a predictive biomarker, the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay detects the folate receptor 1 protein (FOLR1 or FR?), which is over-expressed in most ovarian cancers. The new test identifies ovarian cancer patients eligible for targeted...

BRAINBox Solutions today announced that the company has enrolled the 1,000th patient in the pivotal, HeadSMART II study of its concussion diagnostic and prognostic test, BRAINBox TBI. The multi-national, multi-site, trial is designed to support an...

Gmax Biopharm LLC. announced today that its application of investigation of New Drug (IND) for GMA131 injection, the first global ETa-specific monoclonal antibody, was approved by the US FDA on Nov 11, 2022 for clinical study on diabetic kidney...

Medicines360, a global nonprofit organization with a mission to expand women's access to quality medicines, announced today that the U.S. Food and Drug Administration (FDA) has approved Medicines360's Supplemental New Drug Application (sNDA) to...

Avstera Therapeutics Corp, an oncology-focused biotech dedicated to address the large disease burden and significant unmet need of cancer patients, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation...

Genesis MedTech Group announced today that the Food and Drug Administration (FDA) has approved the Chocolate Touch® Drug-coated Balloon PTA Catheter, developed by TriReme Medical LLC, for the treatment of patients with peripheral artery disease in...

Genesis MedTech Group announced today that the Food and Drug Administration (FDA) has approved the Chocolate Touch® Drug-coated Balloon PTA Catheter, developed by TriReme Medical LLC, for the treatment of patients with peripheral artery disease in...

J INTS BIO announced on November 9th that it had received approval from the US FDA for its Phase 1/2 clinical trial of its Novel Oral 4th Generation EGFR TKI 'JIN-A02' in patients with advanced non-small cell lung cancer (NSCLC)....

Centinel Spine®, LLC, ("the Company") a leading...

Biostrap, a high-resolution biosensor-based digital biomarker platform pioneering the space of clinically reliable biosensors, data processing techniques and remote physiological monitoring, is soon to be releasing Ethos, a...

BrainStorm Cell Therapeutics Inc. , a leading developer of cellular therapies for neurodegenerative diseases, today announced that the company has received a refusal to file letter from the U.S. Food and Drug Administration (FDA) regarding the...

BioLineRx Ltd. , a pre-commercial-stage biopharmaceutical company focused on oncology, today announced that the U.S. Food and Drug Administration (FDA) has accepted...

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....