.jpg){kind=tracking}
“Genome editing is a groundbreaking technology used to introduce intentional genomic alterations in animals and has the potential to improve human and animal health, animal well-being and to enhance food production and quality. It is paramount, however, that as we move forward, we maintain standards of safety and effectiveness.
.jpg){kind=tracking}
CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced that the company has submitted a pre-market approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for the HeartLight X3 Endoscopic Ablation System for the treatment of AFib.
Koura's Zephex® 152a facilitates greater than 90% reduction in inhaler carbon footprints compared to current MDIs
The U.S. Food and Drug Administration and the Federal Trade Commission today signed a joint statement regarding enhanced collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products.
Elixicure's Over-The-Counter Drug Registration has been Certified by the U.S. Food and Drug Administration (FDA) for its Elixicure CBD-Infused Pain Relief products following a successful year-long process, announced Elixicure Chief of Business Development Yaniv Kotler.
Sony Electronics has received FDA 510(k) clearance from the Food and Drug Administration for the company's NUCLeUS™ Operating Room, Imaging Management and Collaboration Control platform.
GOJO took immediate action to respond to FDA claim requirements after receiving a warning letter from the agency on January 17.
.jpg){kind=tracking}
The American Association of Orthodontists (AAO) - in the interests of the health, safety, and well-being of patients seeking orthodontic care - reports that on January 6, nine members of the U.S. House of Representatives authored a letter to the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) "to express [their] concern regarding SmileDirectClub."
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has granted priority review for the New Drug Application (NDA) for selpercatinib (LOXO-292), for the treatment of patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer.
American Regent, Inc. announced the introduction of FDA approved Zinc Sulfate Injection, USP.
.jpg){kind=tracking}
An effortless patient experience combined with actionable clinical intelligence to bring medical-grade care to the home
.jpg){kind=tracking}
The Access PCT strengthens industry's most extensive portfolio of in-vitro diagnostic testing for sepsis identification and management
Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and for the treatment of bipolar I disorder.
Minneapolis FDA delays reporting to the patients in Chicago the non-exempt testing of the device affecting 667 patients
Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced the receipt of formal acceptance from the U.S. Food and Drug Administration (FDA) to proceed with its CNM-Au8 as one of the first three drug regimens in the HEALEY ALS Platform Trial being conducted by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital.
.jpg){kind=tracking}
Regulatory approval enables company to expand reach of at-home kits, empowering consumers nationwide to take control of their health
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven" or the "Company"), a biopharmaceutical company with multiple late-stage neuroscience drug candidates in development, announced today that the U.S. Food and Drug Administration (FDA) has notified its collaborators at the Sean M. Healey & AMG Center for Amyotrophic Lateral Sclerosis (ALS) at Massachusetts General Hospital (MGH) that they may proceed with clinical investigation of verdiperstat, Biohaven's novel myeloperoxidase (MPO) inhibitor, in ALS.
.jpg){kind=tracking}
Minneapolis FDA confirms no plan to inform patients of non-exempt medical devices placed in 667 citizens
Company to Initiate First U.S. Clinical Investigation of Allogeneic NK Cell Therapy administered Intravenously or Intratumorally in Patients with Glioblastoma Multiforme (GBM)
.jpg){kind=tracking}
Action aligns with requests from FCS Foundation for FDA to be more flexible and hear the patient voice when considering review of drugs to treat FCS