News by subject: FDA

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalkertm System, the company's first robot-assisted platform for orthopedic applications. The SkyWalkertm System will...

VolitionRx Limited ("Volition"), a multi-national epigenetics company, has appointed Diagnostic Oncology CRO, LLC ("DXOCRO") to undertake development and clinical validation studies for its Nu.Q® product portfolio in the United States. DXOCRO will...

Today, the U.S. Food and Drug Administration approved Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for the treatment of patients with unresectable (unable to be removed) or metastatic (spread to other parts of the body) HER2-low breast...

Vieworks, a leading digital X-ray imaging solution provider based in South Korea, noted that its newest VIVIX-S F series has been authorized by the US Food and Drug Administration (FDA) last July. Regulatory clearance from the FDA will allow Vieworks...

Jubilant Therapeutics Inc., a biopharmaceutical Company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced U.S. Food and Drug Administration (US FDA) clearance of the...

Today, Allergan Aesthetics, an AbbVie company , announced the U.S. FDA approval of JUVÉDERM® VOLUXtm XC for the improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition. 1...

ProfoundBio, an oncology biotherapeutics company focused on the development of novel antibody-based therapeutics, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug application...

Sumitomo Pharma Oncology, Inc., a clinical-stage company focused on novel cancer therapeutics, today announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for DSP-5336, an investigational small molecule inhibitor...

Avenge Bio, Inc. ("Avenge Bio, "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...

REGENXBIO Inc. today announced its intention to file a Biologics License Application (BLA) in 2024 using the FDA's accelerated approval pathway for...

-- ASC10 is an oral double prodrug that is rapidly and completely converted in vivo into the active metabolite ASC10-A, which is the same active metabolite of molnupiravir -- Ascletis has filed multiple patent applications for ASC10 and its use...

Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Cabazitaxel Intravenous Powder (generic for Jevtana Kit®). This product was developed in...

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the...

Biosight Ltd., a pharmaceutical development company focused on the development of innovative therapeutics for hematological malignancies and disorder, announced today that the United States Food & Drug Administration (FDA) has granted Orphan Drug...

Eccogene announced that the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application to commence Phase I trial of its thyroid hormone receptor agonist ECC4703 in U.S. This study will evaluate the safety,...

The Lenstec SBL-3 IOL (Segmented Bifocal Lens) is a next-generation asymmetric multifocal refractive IOL which provides patients with near, intermediate and distance vision.  Its patented design allows for improved contrast sensitivity and minimized...

DyAnsys, Inc., has announced that Primary Relief, a percutaneous electrical neurostimulation device, has been clearedto treat pain following a Caesarean-section (C-section)....

After the first case of monkeypox was reported in the UK in early May, according to data compiled by the US CDC on July 1, 5,783 cases of monkeypox have been reported in 52 countries. Once infected, monkeypox causes headaches along with fever, muscle...

The Lupus Research Alliance (LRA) is pleased to share that the U.S. Food and Drug Administration (FDA) has approved belimumab (Benlysta®) as the first-ever treatment specifically indicated for children aged 5 to 17 with lupus nephritis. Belimumab is...

BIOTRONIK, LAKE OSWEGO, USA, announced that it received U.S. Food and Drug Administration (FDA) approval of its innovative Pulsar®-18 T3 peripheral self-expanding stent system for an improved implantation procedure for endovascular treatments. The...

SOD1-ALS is a rare genetic form of ALS that affects approximately 330 people in the U.S., it is progressive, leads to the loss of everyday functions and is uniformly fatal If approved, tofersen would be the first treatment to target a genetic cause...

B.More Inc., a 501(c)(3) non-profit, clinical-stage biopharmaceutical company focused on the development of psychedelic medicines for substance abuse disorders, today announced the submission of an IND application to begin a Phase 2b trial to...

Nobelpharma America, LLC, a pharmaceutical and medical device company headquartered in Bethesda, Maryland, will debut HYFTORtm (sirolimus topical gel) 0.2%, the first-ever U.S. FDA-approved topical treatment for facial angiofibroma associated with...

QBiotics Group Limited...

Embolx, Inc. a medical device company developing microcatheters for arterial embolization procedures, today announced that the company has filed a 510(k) to the Food and Drug Administration (FDA) for its new product line of high flow microcatheters...

JWEI, a global leader in the electronic cigarette industry, announces today that they have successfully submitted a Pre-Market Tobacco Application to the U.S. Food and Drug Administration for a device created with their new innovative technology,...

Xiaozao Technology, a green economy biotechnology company producing nutrients from microalgae, has received food safety certifications FSSC22000 and ISO 22000:2018 and quality management systems certification ISO9001:2015 for their Guangxi China...

Brand Institute is proud to announce its work with Duchesnay in developing the brand name PHEBURANE®. PHEBURANE® (sodium...

Werfen today announced the 510(k) clearance of the ROTEM sigma Thromboelastometry System by the US Food and Drug Administration (FDA). The ROTEM sigma delivers real-time, rapid and actionable results, now at the point of care (POC), to guide bleeding...

Apyx Medical Corporation , the manufacturer of Renuvion®, a proprietary helium plasma and radiofrequency technology, announces the receipt of 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for the use of Renuvion for use in...

Azurity Pharmaceuticals, Inc., a private pharmaceutical company focused on developing innovative products to serve the specific needs of overlooked patients, today announced the U.S. Food and Drug Administration (FDA) approval of ZONISADEtm...

Escend Pharmaceuticals, Inc., a privately held company focused on the development of small molecule therapeutics for oncology orphan diseases, announced today that the United States Food and Drug Administration (FDA) has cleared its investigational...

Omega Therapeutics, Inc. ("Omega"), today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to...

First Relief, a PENS (percutaneous electrical neurostimulation) device, has been cleared by the US Food and Drug Administration for multiple treatments up to 56 days for symptomatic relief of chronic, intractable pain from diabetic peripheral...

Onkos Surgical, a rapidly growing, leading innovator of solutions for musculoskeletal oncology and complex orthopaedic procedures, today announced that it has received 510(k) clearance for its My3D® Personalized Pelvic Reconstruction system....

MCRA's Regulatory Team was retained by NeuroMetrix to lead the strategy and development of a De Novo submission to the U.S. Food and Drug Administration (FDA) for its Quell Wearable Neuromodulation Device as an aid for reducing the symptoms of...

Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, recently had its Premarket Approval (PMA)...

Centinel Spine now has four PMA approved cervical Total Disc Replacement (TDR) devices, offering the broadest spectrum of solutions to address surgeon preference and individual patient anatomy.The variety of cervical TDR endplate configurations,...

Alpheustm Medical, Inc, a privately held company developing a novel sonodynamic therapy (SDT) platform targeting solid body cancers, today announced the U.S. Food and Drug Administration (FDA) has granted both Orphan Drug and Fast Track Designations...

NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and...

Provepharm, a French company with operations in the United States of America, specializing in the development of pharmaceutical applications, today announced that it has received FDA New Drug Approval for the marketing of its injectable BLUDIGOtm...

Breakthrough Device Designations are given by the U.S. FDA to expedite the review of technologies that can improve the lives of people with life-threatening or debilitating conditionsEach year, 2.8 million Americans will fail multiple depression...

Eko, a digital health company advancing heart and lung disease detection, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Eko Murmur Analysis Software (EMAS) for detecting and characterizing murmurs found in adults...

Citius Pharmaceuticals, Inc. ("Citius" or the "Company") , a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the Company held a Type B pre-BLA meeting with the U.S. Food...

Healthy.io, the global leader in transforming the smartphone camera into a medical device, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for home use of the Minuteful Kidneytm test. This marks...

Medical imaging technology company Adaptix Limited (Adaptix) has submitted a 510(k) application to the U.S. Food and Drug Administration for its first medical imaging product ("NeXt 3D-Ortho"), allowing the company to begin marketing its...

Brand Institute is proud to announce its work with Osmotica Pharmaceuticals in developing the brand name RELEXXII®. RELEXXII®...

Anthos Therapeutics, a clinical-stage...

Singapore-based SCG Cell Therapy Pte Ltd ("SCG") announced that U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for SCG101, an investigational T-cell receptor (TCR) T cell therapy for patients with...

Renovia Inc. ("Renovia"), a developer of non-surgical, treatments for female pelvic floor disorders and an advocate for women's health, announced today that the U.S. Food and Drug Administration (FDA) has cleared its leva® Pelvic Health System for...