News by subject: FDA

Lantern Pharma , a clinical stage biopharmaceutical company using its proprietary RADR® artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development today announced that the U.S. Food...

Magnesium Development Company (MDC), a company with an innovative magnesium (Mg) alloy technology set out to solve what seemed to be an unsolvable problem: the need for a material for use in multiple orthopedic applications that provides appropriate...

Applied Pharmaceutical Science, Inc. ("APS" or "the Company"), has recently announced the Investigational New Drug (IND) application for its self-developed breakthrough new drug APS03118, a next generation selective RET inhibitor, has been approved...

Applied Pharmaceutical Science, Inc. ("APS" or "the Company"), has recently announced the Investigational New Drug (IND) application for its self-developed breakthrough new drug APS03118, a next generation selective RET inhibitor, has been approved...

AbbVie today announced the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA), a systemic inflammatory disease that affects the skin and joints and...

BENDIT Technologies, a company focused on the development of steerable microcatheters, announced today the successful first use in the USA of the BENDIT21 neuro catheter in a life-saving treatment. The case involved a 57-year-old female patient who...

Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug...

Nuvation Bio Inc. , a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the U.S. Food and Drug Administration (FDA) has cleared its...

CASI Pharmaceuticals, Inc. , a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announced today, that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug...

AN2 Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, announced today that the U.S. Food and Drug Administration (FDA) cleared the...

Neurophth Therapeutics, Inc., (hereinafter referred to as "Neurophth"), today announced receiving the U.S. Food and Drug Administration (FDA) clearance of its investigational new drug (IND) application on the in-vivo gene replacement therapy NR082...

Pathogenomix Inc., a Next Generation Sequencing, pathogen diagnostic company, announced that the US Food and Drug Administration (FDA) has granted it a Breakthrough Device Designation for its Patho-Seq assay. Patho-Seq is designed for the rapid...

Nevro Corp. , a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced receipt of FDA approval for expanded labeling for its Senza® Spinal Cord Stimulation (SCS)...

Clarius Mobile Health is first to introduce a third-generation product line of high-performance handheld wireless ultrasound scanners for all medical specialists. Now 30% lighter and smaller, the new pocket-sized scanners are available today in the...

SoftSmile, a leading medical technology company based in NY, and developer of advanced orthodontic software solutions, announced its software device was cleared by the U.S. Food and Drug Administration (FDA) pursuant to a 510(k) pre-market...

Hip Innovation Technology, LLC (HIT), a medical device company developing innovative orthopedic device solutions to advance the quality of life and quality of care for patients, has received FDA (Food and Drug Administration) Investigational Device...

PolarityTE, Inc. , a biotechnology company developing regenerative tissue products and biomaterials, today announced that the U.S. Food and Drug Administration (FDA) has approved its investigational new drug (IND) application for the evaluation of...

Endo Tools Therapeutics (ETT), developers of advanced endoscopic medical devices for use by gastroenterologists, today announces the U.S. Food and Drug Administration (FDA) 510(k) clearance of the endomina® system, designed for endoscopic placement...

BioLineRx Ltd. a late clinical-stage biopharmaceutical company focused on oncology, today announced that the Company has completed a successful pre-New Drug Application (NDA) meeting with the US Food and Drug Administration (FDA) regarding...

Diadem U.S., Inc.,(a subsidiary of Diadem Srl) a company developing the first blood-based test for the early prediction of Alzheimer's disease (AD), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device...

Jacobio's self-developed global first-in-class drug Aurora A inhibitor  JAB-2485 received IND (Investigational New Drug) from the FDA (Food and Drug Administration) in US. Jacobio plans to initiate a Phase I/IIa clinical trial in patients with...

AbbVie today announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib) for the treatment of moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease did not respond to...

Glenmark Pharmaceuticals Limited, a research-led, global integrated   pharmaceutical company announced that its fully owned subsidiary Glenmark Specialty S.A. (Switzerland), received FDA approval on its New Drug Application (NDA) for Ryaltristm, an...

We are advised by RapidRona that journalists and other readers should disregard the news release, FDA Grants Emergency Use Authorization to Premier Medical Laboratory Services for At-home COVID-19 Test, issued 13-Jan-2022 over PR Newswire. SOURCE...

Premier Medical Laboratory Services (PMLS), one of the largest private medical diagnostics laboratories in the US has provided results for millions of COVID-19 tests since the beginning of the pandemic, contributing largely to the national COVID-19...

Today, the U.S. Food and Drug Administration approved Solensia (frunevetmab injection), the first treatment for the control of pain associated with osteoarthritis in cats and the first monoclonal antibody (mAb) new animal drug approved by the FDA for...

Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of the Johnson & Johnson Medical Devices Companies** today announced that the U.S. Food and Drug Administration (FDA) approved the MENTOR® MemoryGel BOOSTtm Breast...

Wavegate Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its StimuLuxtm optical reflectometry system for closed-loop adaptive modulation of spinal cord stimulation. The FDA's...

Andelyn Biosciences, a pioneering cell and gene therapy CDMO born out of Nationwide Children's Hospital, today announced the U.S. FDA's acceptance of its GMP plasmid DNA drug master file (DMF), which enables the organization to vertically integrate...

Abbott  today announced it has received clearance from the U.S. Food and Drug Administration for the EnSitetm X EP System with EnSite Omnipolar Technology (OT), a new cardiac mapping platform available in the U.S. and across Europe that is designed...

Cellular Biomedicine Group Inc. (CBMG or the "Company"), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, today announced that the Food and Drug Administration (FDA) granted C-CAR039, a novel...

Cochlear Limited , the global leader in implantable hearing solutions, obtained U.S. Food and Drug Administration (FDA) approval of Cochleartm Nucleus® Implants for the treatment of unilateral hearing loss (UHL)/single-sided deafness (SSD).  ...

SNIPR BIOME ApS, a leading CRISPR and microbiome biotechnology company, is pleased to announce that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) Application, for our first development candidate, enabling...

Medtronic plc , a global leader in healthcare technology, today announced it has received approval from Japan's Ministry of Health, Labor and Welfare for the sale and reimbursement of the Micratm AV Transcatheter Pacing System (TPS), and the company...

The approval of QUVIVIQtm ? 25 & 50 mg ? is based on a robust Phase 3 clinical program that demonstrated significant improvement versus placebo on objective measures of sleep onset and sleep maintenance, as well as patient reported total sleep time...

Medtronic plc , a global leader in healthcare technology, today announced the National Medical Products Administration (NMPA) has approved the CoreValvetm Evoluttm PRO TAVR system for the treatment of severe aortic stenosis (AS) for symptomatic...

COUR Pharmaceuticals, a biotechnology company developing novel immune-modifying nanoparticles (CNPs) to treat immune disorders, today announced the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to the Company's...

Amgen today announced that the European Commission (EC) has granted conditional marketing authorization for LUMYKRAS® (sotorasib), a first-in-class KRASG12C inhibitor, for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with...

BD (Becton, Dickinson and Company) , a leading global medical technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the BD Kiestratm IdentifA system, which is designed to...

Dynacure, a clinical stage biotechnology company focusing on Myotubular and Centronuclear Myopathies (CNM), a group of rare, debilitating, and life-threatening genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has...

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 (FDA) clearance of the...

COPAN Diagnostics is proud to announce the FDA clearance of Colibritm, an automated processor that is a complementary part of WASPLab®, COPAN's full laboratory automation system. The COPAN Colibritm System is an in vitro diagnostic device for use in...

Helios Cardio Inc. announces the Food and Drug Administration (FDA) 510(k) clearance for commercial distribution of CardiaMendtm Pericardial and Epicardial Reconstruction Matrix....

Meridian Bioscience, Inc. , a leading global provider of diagnostic testing solutions and life science raw materials, announced today that the Curian® Campy assay has received U.S. Food and Drug Administration (FDA) clearance.  The Curian Campy assay...

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has granted approval for an amendment to the company's...

NuVasive, Inc. , the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the Company received U.S. Food and Drug Administration (FDA) 510(k)...

Biohaven Pharmaceutical Holding Company Ltd. and Pfizer Inc. , today announced that the parties have completed the collaboration transaction between the two companies. The transaction agreements, including Pfizer's commercialization of rimegepant...

URO-1 Inc., www.uro1medical.com, an innovator of medical devices for urology and urogynecology, today announced achievement of multiple milestones toward commercializing its breakthrough products for prostate biopsy and other procedures....

Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved new expanded magnetic resonance imaging (MRI) compatibility for its Proclaimtm XR Spinal Cord Stimulation (SCS) System with Octrodetm leads. The new labeling lifts...

AbbVie announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to investigational telisotuzumab vedotin (Teliso-V) for the treatment of patients with advanced/metastatic epidermal growth factor...