News by subject: FDA

FDA approval of ZILBRYSQ® (zilucoplan) has been granted for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive1ZILBRYSQ is the first once-daily subcutaneous, targeted C5...

Alcami Corporation ("Alcami"), a leading contract development and manufacturing organization (CDMO), today welcomed the recent announcement by Nectero Medical that they have received clearance from the U.S. Food and Drug Administration of their IND...

FloBio, a medical diagnostics company, announced today that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. The FDA recognizes that the device will provide for more...

Werfen today announced 510(k) clearance of Aptiva® Connective Tissue Disease (CTD) Essential reagent by the US Food and Drug Administration (FDA)....

Everest Medicines (HKEX 1952.HK) announced today that its licensing partner, Pfizer Inc. has received approval from the U.S. Food and Drug Administration (FDA) for VELSIPITYtm (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate (S1P)...

A promising cancer innovation developed at Roswell Park Comprehensive Cancer Center has been granted Fast Track...

MimiVax, Inc., a biotechnology company focused on the development of glioblastoma vaccine therapy, announced today that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to MimiVax's SurVaxM vaccine being...

SentiAR, Inc. a St. Louis, Missouri based pioneer in using Augmented Reality (AR) visualization technology for medical procedures has received their second FDA 510K clearance CommandEPtm adding a new integration....

SnackSafely.com ? a leading food allergy advocacy established in 2011 ? sent a petition with over 20,000 signatures to the FDA and oversight committees in Congress, demanding approval of nasal epinephrine for use in anaphylactic emergencies....

South Rampart Pharma, Inc. ("South Rampart" or the "Company"), a clinical-stage biopharmaceutical company targeting the safer treatment of pain, today announced that the U.S. Food and Drug...

MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance,...

Kyverna Therapeutics ("Kyverna"), a clinical-stage cell therapy company with the mission of...

InfoBionic, Inc. today announced that it received 510(k) clearance from the U.S. Food...

Cellipont Bioservices, a leading CDMO in cell therapy development and manufacturing and Diakonos Oncology, announced today that they have entered into an agreement for the Process Development & cGMP Manufacturing of DOC1021, an autologous dendritic...

Intelivation Technologies, an innovative medical device company with a cutting-edge orthopedic portfolio announced today that it has received clearance from the Food and Drug Administration for its Hammerdesistm Interphalangeal Fusion System. ...

Emergency physicians attending the ACEP23 conference in Philadelphia this week will be the first to see the new Clarius PAL HD3, a wireless handheld whole-body ultrasound scanner combining phased and linear arrays on a single head. This device offers...

TechMah CMF LLC, an innovative medical device company, is pleased to announce the FDA 510(k) approval of its cutting-edge medical device, the tmCMF Solution. This approval marks a significant milestone for the company, reaffirming its dedication to...

AZOVA, a leading innovator in preventive care and at-home diagnostics, is proud to announce the introduction of its revolutionary UTI Telehealth Bundle now available on Walmart.com and in select stores. Designed for rapid, convenient, and accessible...

Naitive® Technologies, a population health company, has received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for OsteoSighttm, its technology for estimating bone mineral density (BMD) from routine X-rays....

Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, announced that its...

First new intravenous (IV) treatment option in six years for adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)1-6 Cosentyx® (secukinumab) administered via IV infusion offers...

GC Biopharma Corp. announced today that GC1126A, its drug candidate for Thrombotic Thrombocytopenic Purpura (TTP), received an Orphan Drug Designation on September 27 from the U.S. Food and Drug Administration (FDA)....

In the news release, French MedTech BodyCAP launches its "eCelcius Medical System", a connected ingestible thermometer for medical applications in the United States, issued Oct. 4, 2023 by BodyCap over PR Newswire, we are advised by the company that...

The U. S. Food and Drug Administration (FDA) has awarded Lipogems another Investigational Device Exemption (IDE) study for the use of MicroFat for the treatment of knee osteoarthritis (OA). The second IDE Study will be conducted for the safety and...

Dimension Inx, a biomaterials platform company, today announced that CMFlextm, the first 3D-printed regenerative bone graft product with FDA approval, has been successfully used in its first clinical cases....

BodyCAP, a French MedTech company, has taken another step forward with the approval of its "eCelsius Medical System" connected medical device by the US Food and Drug Administration (FDA). This thermometer, integrated into a capsule that is simply...

Sesh Products US, Inc. (Sesh) is pleased to announce that its Premarket Tobacco Product Applications (PMTAs) have been accepted for review by the U.S. Food and Drug Administration (FDA). In compliance with the May 14, 2022, deadline for then-marketed...

The U.S. Food and Drug Administration (FDA) has granted approval for EntroGen's CRCdx® RAS Mutation Detection Kit as a companion diagnostic for Vectibix® (panitumumab), a targeted therapy used in the treatment of colorectal cancer. This landmark...

Novavax, Inc. , a global company advancing protein-based vaccines with its novel...

Invitae , a leading medical genetics company, today announced it gained FDA market authorization for its Common Hereditary Cancers Panel....

EQUASHIELD®, a leading provider of Closed System Transfer Devices (CSTDs) for hazardous drugs, is thrilled to announce that its EQUASHIELD® Syringe Unit has received FDA clearance for full-volume use: "The system's closed Syringe Unit prevents...

ProciseDx Inc. announces that it has been granted de novo FDA clearance for the therapeutic drug monitoring (TDM) tests for adalimumab (Humira® and biosimilar Amgevita®) and infliximab (Remicade® and biosimilars Inflectra® and Renflexis®)....

 Investigational Device Exemption (IDE) approval by the U.S. Food and Drug Administration (FDA) allows AcelRx to begin pivotal study of Niyadtm Single registration study with pre-agreed upon endpoints planned to initiate in Q4 2023 with topline data...

The "Rare Hemophilia Factors Market Size, Share & Trends Analysis Report By Type (Factor I, Factor II, Factor VII), By Treatment (Factor Concentrates, Fresh Frozen Plasma, Cryoprecipitate), By Region, And Segment Forecasts, 2023 - 2030" report has...

Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved RivflozaTM (nedosiran) injection 80 mg, 128 mg, or 160 mg, a once-monthly subcutaneous ribonucleic acid interference (RNAi) therapy, to lower urinary oxalate...

Hoth Therapeutics, Inc. , a patient-focused biopharmaceutical company, today announced the Pre-IND meeting requested on September 8th for HT-KIT with the U.S. Food and Drug Administration (FDA) has been granted to receive written responses only from...

Avenge Bio, Inc. ("Avenge" or the "Company"), a biotechnology company developing the LOCOcytetm Immunotherapy platform for the precision administration of potent immune effector molecules to treat solid tumors, today announced that the U.S. Food...

Boehringer Ingelheim announced today that Adalimumab-adbm injection, the company's interchangeable* biosimilar to Humira® (adalimumab), is now available at a low wholesale acquisition cost (WAC). Adalimumab-adbm is approved to treat multiple chronic...

Enable Injections, Inc. ("Enable") today announced that the U.S. Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse®) for the subcutaneous delivery of EMPAVELI® (pegcetacoplan), which is commercialized in the United States...

NRx Pharmaceuticals, Inc. ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that FDA has given the company clearance to proceed with human trials to treat Chronic Pain...

WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), congratulates its strategic partner, Amicus Therapeutics ("Amicus") , on receiving U.S. FDA's approval for Pombilititm...

Company Contact:Name: Susan DiCrocePhone Number: (215) 579-1842 Ext: 1260 KVK-Tech, Inc. is voluntarily recalling one lot (Batch Number: 17853A; "the batch") of Betaxolol Tablets, USP 10 mg, White, Round, film coated biconvex tablets, debossed "K"...

Registrar Corp, the leading regulatory compliance services, training, and software firm has introduced their new Adverse Event Reporting software to help cosmetic companies simplify FDA requirements....

Fabre-Kramer Pharmaceuticals Inc. (Fabre-Kramer), a biopharmaceutical company committed to developing novel therapies to address unmet needs in psychiatry and neurology, is pleased to announce that the U.S. Food and Drug Administration (FDA)...

BrainStorm Cell Therapeutics Inc. , a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the outcome of the U.S. Food and Drug Administration's Cellular, Tissue and Gene Therapies Advisory...

4WEB Medical, an orthopedic implant company focused on developing innovative implants that utilize its proprietary Truss Implant Technologytm, announced that it has received 510K clearance to market the newest additions to the company's implant...

Calliditas Therapeutics AB ("Calliditas") today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Alport syndrome with setanaxib. Based on supportive...

EnCompass Technologies, Inc., a privately held medical device company focused on protecting patients from brain injury during cardiovascular procedures, announced the US Food and Drug Administration (FDA) officially granted conditional...

Viatris Inc. , a global healthcare company, and Ocuphire Pharma, Inc. , a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye...

Laminate Medical Technologies (Laminate) has announced their flagship device, the VasQ External Vascular Support, has been cleared by the FDA for use to create arteriovenous fistulas (AVFs) for dialysis access. The device, designated by the FDA as a...