News by subject: FDA

Today, Getinge announces the U.S. Food and Drug Administration's (FDA) 510(k) clearance of the Vasoview Hemopro 3, the latest addition to the medtech company's endoscopic vessel harvesting (EVH) solutions. Designed with customer centricity top of...

Drugmaker Eli Lilly & Company today announced the FDA expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to further review and discuss donanemab's efficacy and safety profile before making its final...

Verismo Therapeutics, a clinical-stage CAR-T company developing the novel KIR-CAR platform technology, today announced that it has activated a second clinical site for its STAR-101 Phase 1 clinical trial at The University of Texas MD Anderson Cancer...

CSL Seqirus, a global leader in the protection of public health, confirmed it is fully prepared to deliver its influenza vaccine portfolio for the 2024/25 U.S. season, based on the trivalent strains recommended this week by the U.S. Food and Drug...

Vanda Pharmaceuticals Inc. (Vanda) today announced that on March 4, 2024, it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA)...

Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not...

Clear Guide Medical proudly announces the FDA clearance for the CLEAR GUIDE SCENERGY computer aided instrument guidance system, alongside the new TP Access Tool with SteriGRIDtm....

SEKISUI Diagnostics, a global medical diagnostics manufacturer, has received EUA clearance for the OSOM Flu SARS-CoV-2 Combo Test for use in professional and home testing settings....

Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH, world-leading producer of diagnostic tests, equipment, and research products in the field of blood clotting and its exclusive distributor in the USA, DiaPharma Group, Inc., are pleased...

Today, Allergan Aesthetics, an AbbVie company , announced the U.S. FDA approval of JUVÉDERM® VOLUMA® XC for injection in the temple region to improve moderate to severe temple hollowing in adults over the age of 21.1 JUVÉDERM® VOLUMA® XC is the first...

Analog Devices, Inc.  today announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the commercial launch of the Sensineltm Cardiopulmonary Management (CPM) System. The compact wearable device is a non-invasive, remote management...

PhotonPharma, a biotechnology company dedicated to revolutionizing cancer treatment, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with its Phase I clinical study for the treatment of Stage...

Ellipses Pharma ("Ellipses"), a global drug development company focused on accelerating the development of cancer treatments through an innovative drug development model, announced today that it has received Fast Track designation from the U.S. Food...

Taiwan-based Formosa Pharmaceuticals (6838.TWO) and AimMax Therapeutics (United States) announced today that the U.S. Food and Drug Administration (FDA) has approved clobetasol propionate ophthalmic suspension 0.05% (APP13007), for the treatment of...

Today, the pharmaceutical company Perrigo announced that it will begin shipping the first ever FDA-approved over-the-counter daily oral contraceptive pill, Opill, to retailers across the country. This marks a historic advancement in access to...

Hugel America, Inc., a division of Hugel Inc., a global leader in the medical aesthetics industry, today announced it received United States (U.S.) Food and Drug Administration (FDA) approval on its neurotoxin, Letybo to treat moderate-to-severe...

BioLineRx Ltd. , a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that it has received...

Hugel, a global total medical aesthetics company, announced that the company has received marketing approval from the U.S. Food and Drug Administration(FDA) on the 29th(local...

Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to CBL-514 for Dercum's disease treatment. CBL-514 is a lipolysis injection that can reduce local subcutaneous fat...

Approval is based on results from the Phase 3 PAPILLON study, which demonstrated RYBREVANT® plus chemotherapy reduced the risk of disease progression or death by 61 percent versus chemotherapy alone in patients with previously untreated NSCLC with...

? Acthar Gel Single-Dose Pre-filled SelfJect Injector is a self-controlled, pre-filled delivery device1 for appropriate patients with a range of chronic and acute inflammatory and autoimmune conditions2 ? ? This first-in-class delivery device reduces...

Boston Scientific Corporation today announced it has received U.S. Food and Drug Administration (FDA) approval for the AGENTtm Drug-Coated Balloon (DCB), which is indicated to treat coronary in-stent restenosis (ISR) in patients with coronary artery...

Spatz Medical, a global leader in gastrointestinal weight loss solutions, is delighted to announce the commencement of commercialization of the Spatz3 Adjustable Gastric Balloon. With over 150,000 patients benefiting from the Spatz3 across more than...

Varian, a Siemens Healthineers company, announced that it has received 510(k) clearance from the U.S. Food...

LISCure Biosciences, a leading clinical-stage biopharmaceutical company focused on discovering and developing innovative microbiome-based therapies, announces the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug...

Woven Orthopedic Technologies, developer of Ogmend®, a simple implantable sleeve that quickly and easily secures stable screw fixation, has received its second 510(k) clearance from the Food and Drug Administration (FDA) for the use of...

SN Bioscience Co. Ltd. (CEO Park Young-hwan) announced on Feb 27 that the US FDA had granted an orphan drug designation for pancreatic cancer for SNB-101 (API: SN-38), a new polymer nanoparticle drug under development, based on the pre-clinical data...

Nevro Corp. , a global medical device company delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that the U.S. Food and Drug Administration (FDA) cleared its sacroiliac joint fusion device, which will...

Workflow Services, a comprehensive and automated platform that solves point-of-care clinical service delivery for pharmacies, marked a major milestone in its partnership with the FDA in its groundbreaking Diagnostic Data Program. In the 100 days...

LTS LOHMANN Therapie-Systeme AG ("LTS"), a leading pharmaceutical technology company, announced today that its customer Coherus BioSciences, Inc ("Coherus") has launched its UDENYCA® on-body injector (OBI) utilizing the LTS Sorreltm wearable drug...

ARTHEx Biotech S.L., a clinical-stage biotechnology company focused on developing innovative medicines through the modulation of microRNAs, announced that the U.S. Food and Drug Administration (FDA) cleared the Company to initiate the Phase I-IIa...

Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces that its self-developed novel ADC drug targeting Nectin-4 (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug...

AbbVie today announced that the U.S. Food and Drug Administration (FDA)...

Virtual Incision, a cultivate(MD) portfolio company, has been granted marketing authorization of the MIRAtm Surgical System (MIRA) from the FDA. This marks a significant milestone as MIRA becomes the first miniaturized robotic-assisted surgery device...

Nuvalent, Inc. , a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough...

EnsoData, a pioneer in healthcare AI, achieved FDA 510(k) clearance for groundbreaking technology that enables AI-powered sleep diagnosis using FDA-cleared pulse oximetry (pulse ox) devices. Powered by EnsoSleep PPG scoring, widely available and...

Detailed results from the NIH-sponsored Phase III OUtMATCH study showed treatment with Xolair increased the amount of peanuts, tree nuts, egg, milk and wheat that people as young as 1 year consumed without an allergic reactionThe US FDA recently...

Immunofoco, a company dedicated to developing cell therapy products for solid tumors, announced a significant milestone, that following the approval by the CDE in China for the clinical trial application of IMC001, an EpCAM-targeting autologous CAR-T...

ChemoMouthpiece, LLC. announces the FDA 510(k) Marketing Clearance for their device, The Chemo Mouthpiecetm.  The Chemo Mouthpiecetm is intended to be used to cool the oral mucosa to reduce the incidence and severity of chemotherapy induced oral...

With the annual vector season coming up, University Products recently underscored the critical importance of early vaccination against bovine anaplasmosis to reduce herd losses. Offering a sensible and budget-friendly solution for cattle farmers...

Zimmer Biomet Holdings, Inc. , a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the ROSA® Shoulder System for robotic-assisted shoulder replacement surgery. ROSA Shoulder is the world's...

If approved, vorasidenib would be the first targeted therapy in IDH-mutant diffuse glioma, a malignant and incurable brain tumor In clinical studies, vorasidenib has demonstrated strong blood-brain barrier penetrance alongside clinically meaningful...

The U.S. Food and Drug Administration granted Sira Medical 510(k) clearance for its augmented reality preoperative surgical planning application, which provides clinicians with advanced imaging to assist in making key patient management decisions....

X-trodes, a bio-convergence company bringing wireless monitoring solutions to the home environment, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for X-trodes' Smart Skin solution (marketed as X-trodes...

Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TECVAYLI® (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W)...

MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its role in the successful 510(k) clearance decision by the U.S. Food and Drug...

Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that FDA has granted Orphan Drug Designation (ODD) to 9MW3011 (R&D code in the US: MWTX-003/DISC-3405) for the treatment of patients with polycythemia...

Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its clinical trial application of B7-H3 targeting ADC (R&D code: 7MW3711) for advanced malignant solid tumor was approved by the U.S. Food and...

Avidity Biosciences, Inc. , a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCstm), today announced that the U.S. Food and Drug Administration (FDA) has granted Rare...

X-trodes, a bio-convergence company bringing wireless monitoring solutions to the home environment, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for X-trodes' Smart Skin solution (marketed as X-trodes...