News by subject: FDA

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...

Harmony Biosciences Holdings, Inc. , announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to pitolisant for the treatment of Prader-Willi syndrome (PWS)....

WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, today announced that the U.S. Food and Drug Administration (FDA) has approved its Philadelphia site to begin the analytical testing and manufacturing of AMTAGVI for...

Today, the U.S. Food and Drug Administration approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to...

Today, the U.S. Food and Drug Administration approved Xolair (omalizumab) injection for immunoglobulin E-mediated food allergy in certain adults and children 1 year or older for the reduction of allergic reactions (Type I), including reducing the...

Approval is based on data from the NIH-sponsored Phase III OUtMATCH study, which showed a significantly higher proportion of food allergy patients as young as 1 year treated with Xolair could tolerate small amounts of peanut, milk, egg and cashew...

Curadev is excited to introduce CRD3874, a first-in-class allosteric small molecule STING agonist, with distinct pharmacological properties that distinguish it from agents that bind to STING's cGAMP site. An intravenous formulation of this lead asset...

Caliway Biopharmaceuticals (Caliway) announced that the...

SightGlass Vision, a joint venture of CooperCompanies and EssilorLuxottica that develops innovative technologies and science-based treatments to address the global myopia epidemic, today announced that the U.S. Food and Drug Administration (FDA) has...

Numinus Wellness Inc. ("Numinus" or the "Company") , a mental health care company advancing traditional and innovative behavioral health...

Today, the U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. "This approval provides patients with the first-ever treatment option for severe...

TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company")  a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today announced a shareholder update with a projected...

Efemoral Medical, developer of advanced interventional bioresorbable therapies, today announced that the United States Food & Drug Administration (FDA) has granted its novel Efemoral Vascular Scaffold System (EVSS) Breakthrough Device status for the...

Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, age-related diseases, and chronic hepatitis B (CHB), announced today that it has received clearance from the US Food and Drug...

QT Medical, a medtech company focusing on improving cardiac care with electrocardiogram (ECG or EKG), announces that it has received 510(k) clearance from the FDA for PCA 500tm use in acute care. PCA 500 was first 510(k) cleared in 2018 for...

Pioneering a new approach to treat depression, NeuroQore, Inc. ? a neurotechnology company supported by the Ontario Brain Institute and SOSV ? has received U.S. Food and Drug Administration 510(k) clearance for its groundbreaking neuromodulation...

Edgepark announced today it is offering the newly launched Beta Bionics iLet Bionic Pancreas fully automated insulin delivery (AID) system as part of its comprehensive diabetes management solution portfolio. The iLet is the first and only system that...

Phase 2 trial, expected to begin in 1H 2024, aims to address the unmet medical need of patients suffering from stage 2 or 3 acute kidney injury with associated acute hypoxemic respiratory failure, a condition associated with a high mortality rate...

Tyber Medical LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, has received a U.S. Food and Drug Administration (FDA) 510(k) approval for its Proximal Tibia...