News by subject: FDA

Aucta Pharmaceuticals, Inc. ("Aucta Pharmaceuticals"), announced today the U.S. approval of a generic version of Perforomist®[1] (formoterol fumarate) Inhalation Solution. Formoterol fumarate inhalation solution had annual sales in the U.S. exceeding...

Today, the U.S. Food and Drug Administration approved Rebyota, the first fecal microbiota product approved by the agency. Rebyota is approved for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age...

HemoSonics, LLC, a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced today that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the...

Regeneron Pharmaceuticals, Inc.  today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Evkeeza® (evinacumab-dgnb) as an adjunct...

Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) and its wholly owned subsidiary Cipla USA Inc. (hereafter referred to as 'Cipla'), today announced the launch of Leuprolide Acetate Injection Depot 22.5mg. The product was approved by the United States Food...

OpSens Inc. ("OpSens" or the "Company") , a medical device cardiology-focused company delivering innovative solutions based on its proprietary optical technology, today announced that Dr. Sanjeevan Pasupati, Director of Structural Heart Disease &...

Peptron, Inc. (KOSDAQ: 087010), a leading company in the development of peptide-based sustained-release...

Opteev Technologies, Inc. today announced it has developed an affordable breath analyzer, ViraWarn, that detects COVID-19, Influenza, and RSV in less than 60 seconds. The device, which is multiple-use and rechargeable, has been submitted to the FDA...

Peptron, Inc. (KOSDAQ: 087010), a leading company in the development of peptide-based sustained-release...

Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the confirmatory Phase III trial DIAGNODE-3, evaluating the safety and efficacy of the precision medicine and antigen-specific...

Peer-reviewed results from the Phase 3 open-label extension study of FINTEPLA® in LGS provide significant reduction in the frequency of multiple seizure types associated with a drop or fall for 15 months, including tonic and generalized tonic-clonic...

--The Phase I clinical trial will consist of 3 cohorts in healthy subjects, including single- and multiple-dose escalation studies and food effect study. The objective of Phase I trial is to find a right dose to move into the pivotal Phase II/III in...

Today, the U.S. Food and Drug Administration approved Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who currently use Factor...

Global biotechnology...

Empatica, a digital health and AI company developing medical-grade wearables and algorithms for health monitoring and diagnostics, today announced the clearance of its Empatica Health Monitoring Platform by the U.S. Food and Drug Administration...

Accure Acne, Inc. (www.accureacne.com), a pioneer in the development of innovative solutions for the treatment of acne, announced today it has received FDA clearance for its Accure Lasertm System to treat mild to severe inflammatory acne vulgaris....

The US is the only country with two classes of biosimilars; an interchangeable status is awarded to approved biosimilars after extensive switching and alternating testing in patients; this designation is mandated in the Biological Price Competition...

Triastek, Inc. ("Triastek") a global healthcare company pioneering 3D printing of pharmaceuticals with its proprietary technology, Melt Extrusion Deposition (MED®), announced today that it has received clearance for its Investigational New Drug (IND)...

Jazz Pharmaceuticals plc today announced the U.S. Food and Drug Administration (FDA) approval of a supplemental Biologics License Application (sBLA) to add a Monday/Wednesday/Friday (MWF) intramuscular (IM) dosing schedule for Rylaze®...

JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization, applauds today's decision from the U.S Food and Drug Administration to approve Provention Bio's Tzieldtm (teplizumab-mzwv). Tzield is the first disease-modifying...

Today, the U.S. Food and Drug Administration approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes. "Today's approval of...

TZIELD is the first disease-modifying therapy in T1D, a life-threatening autoimmune diseaseIn a clinical trial, in Stage 2 T1D patients, TZIELD delayed the median onset of Stage 3 T1D by 25 months, or approximately 2 years, compared to placeboStage 3...

Aidoc, the leading provider of healthcare AI solutions, today announced it has increased its FDA clearances to 11 with the addition of CT-based AI solutions - aortic dissection (AD) and all vessel occlusions (VOs). These clearances continue Aidoc's...

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...