FDA Update: June medical device recalls
Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.
Latest News
OMEROS CORPORATION: Announces Agreement with FDA on Primary Endpoint for Narsoplimab BLA in Stem Cell Transplant-Associated TMA
All Criteria for the Response-Based Endpoint Now Finalized
SYNDAX PHARMACEUTICALS: Announces FDA Clearance of IND Application for Targeted Menin Inhibitor SNDX-5613 for Relapsed/Refractory Acute Leukemias
SNDX-5613 is a potent, highly selective, oral inhibitor of the interaction of Menin with the Mixed Lineage Leukemia (MLL) protein
DISCGENICS, INC.: First Utahns treated in nationwide FDA-allowed clinical study of locally developed cell therapy for chronic low back pain
DiscGenics, Inc., a clinical stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, announced the first Utahns have been treated in its nationwide clinical study of IDCT, a locally developed injectable disc cell therapy for degenerative disc disease (DDD).
LA ROCHE-POSAY: Changes The Face Of Acne With Latest FDA Approved Acne Ingredient And Premieres Artificial Intelligence-Based Skin Analysis
La Roche-Posay Launches Effaclar Adapalene Gel 0.1% Acne Treatment and My Skin Track PoreScan
ABBOTT: Announces FDA Approval of the Alinity™ s System, the Latest Technology for Screening and Protecting the U.S. Blood and Plasma Supply
Alinity™ s System will screen the U.S. blood and plasma supply faster and more efficiently while maintaining highest levels of accuracy
SENSORION: Receives FDA IND Approval for Arazasetron (SENS-401)
Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN) a pioneering clinical-stage biopharmaceutical company which specializes in the development of novel therapies to restore, treat and prevent inner ear diseases such as hearing loss, tinnitus and vertigo, announces that it has received the Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to proceed with SENS-401, based on preclinical data and clinical development plan.
BAYER: FDA approves Bayer's Gadavist® (gadobutrol) injection as the first and only contrast agent for use in cardiac MR in adult patients with known or suspected coronary artery disease
Coronary artery disease (CAD) is an important public health issue-- a disease that affects 16.5 million Americans
TEVA PHARMACEUTICAL INDUSTRIES LTD: Teva Announces FDA Approval of AirDuo® Digihaler™ (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder
The First Digital Maintenance Asthma Inhaler Therapy with Integrated Sensors Joins Teva’s Digital Rescue Inhaler Therapy to Provide Patients with Technology to Track Treatment Use
ASTELLAS PHARMA INC.: Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer
Submission Based on Pivotal Phase 2 Trial Results Recently Presented at Annual Meeting of American Society of Clinical Oncology
Dravet Syndrome drug submitted for investigation
An investigational new drug application and fast track designation request for EPX-100, a treatment for Dravet Syndrome, were submitted to the Food and Drug Administration.
Treatment approved for rhinosinusitis with nasal polyps
Dupixent, an injectable medication, was approved by the Food and Drug Administration for the treatment of chronic rhinosinusitis (prolonged inflammation of the sinuses and nasal cavity) with nasal polyps (growths on the inner lining of the sinuses).
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U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new treatment for complicated urinary tract and complicated intra-abdominal infections
The U.S. Food and Drug Administration has approved Recarbrio (imipenem, cilastatin and relebactam), an antibacterial drug product to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).
ERCHONIA: FDA Clears Erchonia's FX 635 for Relief of Chronic Musculoskeletal Pain
Erchonia Corporation, the global leader in the manufacturing and development of low level laser therapy technology ("3LT"), announces that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its FX 635 low level laser for the temporary relief of chronic, nociceptive musculoskeletal pain.
MERCK: FDA Approves Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) For the Treatment of Adults with Complicated Urinary Tract and Complicated Intra-Abdominal Bacterial Infections Where Limited or No Alternative Treatment Options Are Available
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved RECARBRIO™ (imipenem, cilastatin, and relebactam) for injection, 1.25 grams, a new combination antibacterial. RECARBRIO is indicated in patients 18 years of age and older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
FDA approves fast-tracking of Parkinson’s treatment
The Food and Drug Administration has Fast Tracked a drug that could provide treatment for those who have Parkinson's Disease
30 food, dietary supplement recalls initiated
Food producers carried out 30 food or dietary supplement product recalls over the past month, according to the U.S. Food and Drug Administration.
ALLERGAN PLC: U.S. FDA Accepts Allergan's New Drug Application for Bimatoprost Sustained-Release in Patients with Open-Angle Glaucoma or Ocular Hypertension
Allergan continues advancement in eye care innovation, developing specialized treatments for patients
PEAR THERAPEUTICS: Announces FDA Submission for Somryst™, a Prescription Digital Therapeutic for the Treatment of Adults with Chronic Insomnia and Depression
The pending submission is supported by data from two randomized controlled clinical trials of more than 1,400 patients
NACS outlines proposals to combat vape sales to minors
With the rise of e-cigarettes and other popular vape products being consumed by young people, government entities are scrambling to find a solution to address the problem.