Wednesday, February 19, 2020

Wednesday, February 19, 2020

Latest News

U.S. FDA: FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process

The U.S. Food and Drug Administration today approved three drugs for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch.

SOLIGENIX: FDA Grants Soligenix "Fast Track" Designation for RiVax® in the Prevention of Ricin Poisoning

Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its RiVax® (heat stable ricin toxin vaccine) development program for prevention of ricin intoxication has received "Fast Track" designation from the US Food and Drug Administration (FDA).

EYEYON MEDICAL: Breakthrough Device Designation Received From the FDA for EndoArt®

EyeYon medical Ltd. announces Breakthrough Status Designation from the U.S. Food and Drug Administration (FDA) for its EndoArt®, Artificial Endothelial Layer Implant.

CAPTION HEALTH: FDA Grants Caption Health Landmark Authorization for First AI-Guided Image Acquisition System

Caption Guidance™ uses artificial intelligence to empower medical professionals without specialized training to perform cardiac ultrasound

U.S. FDA: FDA Authorizes Marketing of First Cardiac Ultrasound Software That Uses Artificial Intelligence to Guide User

U.S. Food and Drug Administration authorized marketing of software to assist medical professionals in the acquisition of cardiac ultrasound, or echocardiography, images.

U.S. FDA: FDA Expertise Advancing the Understanding of Intentional Genomic Alterations in Animals

“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.

CARDIOFOCUS: Announces U.S. FDA PMA Supplement Submission For The Breakthrough HeartLight X3 Endoscopic Ablation System

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: 'Green' Medical Propellant Receives FDA Approval to Proceed to Clinical Trials

Koura's Zephex® 152a facilitates greater than 90% reduction in inhaler carbon footprints compared to current MDIs

U.S. FDA: FDA and FTC Announce New Efforts to Further Deter Anti-Competitive Business Practices, Support Competitive Market for Biological Products to Help Americans

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.

HONEST GLOBE: Elixicure CBD-Infused Pain Relief Product Listing Receives FDA Certification

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: Announces FDA Clearance for NUCLeUS, the Smart Operating Room Platform, for Sale in the U.S.

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: Takes Immediate Action on Communication from the FDA

GOJO took immediate action to respond to FDA claim requirements after receiving a warning letter from the agency on January 17.

AAO: Reports Congressmen Write Letter to the FDA and FTC Regarding SmileDirectClub, While California Board of Dentistry Moves to Dismiss SmileDirectClub's Lawsuit

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."

LILLY: Receives FDA Priority Review for the Selpercatinib New Drug Application

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: Introduces FDA Approved Zinc Sulfate Injection, USP

American Regent, Inc. announced the introduction of FDA approved Zinc Sulfate Injection, USP.

BECKMAN COULTER DIAGNOSTICS: Beckman Coulter's Access PCT Procalcitonin Assay receives U.S. FDA 510(k) clearance

The Access PCT strengthens industry's most extensive portfolio of in-vitro diagnostic testing for sepsis identification and management

ALKERMES: Announces U.S. Food and Drug Administration Acceptance of ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder

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.

CLENE NANOMEDICINE: Announces Formal Acceptance of CNM-Au8 for HEALEY ALS Platform Trial as Center Receives FDA Approval to Proceed

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.

FDA Reporter