Sunday, February 16, 2020

Sunday, February 16, 2020

Latest News

Xarelto proven to reduce blood clots and medical costs for morbidly obese patients

Xarelto has proved to reduce the risk of recurrent venous thromboembolism (VTE), blood clots, in patients who are also suffering from morbid obesity.

Bongo Rx may replace the CPAP for treatment of mild to moderate sleep apnea

More than 70 percent of 200 patients with mild to moderate sleep apnea participating in a Qualtrics Survey conducted September 4 though September 11 selected the FDA-approved Bongo Rx as their preferred choice over a traditional CPAP.

V-Wave heart treatment receives manufacturer's second FDA Breakthrough Device Designation

The U.S. Food and Drug Administration (FDA) recently awarded a second Breakthrough Device Designation for V-Wave Ltd.’s interatrial shunt for pulmonary arterial hypertension (PAH).

British American Tobacco supports FDA's anti-vaping efforts

British American Tobacco CEO Kingsley Wheaton recently released a statement addressing the U.S. Food and Drug Administration’s work to prevent minors from vaping.

Lilly accepted to FDA’s Complex Innovative Trial Designs Pilot Meeting Program

Eli Lilly and Co. was recently accepted into the U.S. Food and Drug Administration’s (FDA) Complex Innovative Trial Designs (CID) Pilot Meeting Program.

Omega passes FDA's initial Establishment Inspection Report

Omega Laboratories Limited, a Canadian-based subsidiary of Nichi-Iko Pharmaceutical Co., Ltd., and Sagent Pharmaceuticals, Inc., recently passed its initial Food and Drug Administration (FDA) Establishment Inspection Report and will now be allowed to manufacture FDA-approved products.

Drawbridge Health's new blood collection device receives 510(k) clearance

Drawbridge Health received 510(k) clearance from the Food and Drug Administration for its’ OneDraw A1C Test System on Aug. 22.

Super antioxidant Ergothioneine achieves GRAS status

The super antioxidant called ergothioneine or ErgoActive by ingredient supplier and manufacturer Blue California has achieved Generally Recognized as Safe (GRAS) status from the Food and Drug Administration (FDA) under its intended conditions of use.

Eylea Injection Prefilled Syringe approved by FDA

The Eylea Injection Prefilled Syringe received the Chemistry, Manufacturing and Controls Prior-Approval Supplement by the Food and Drug Administration (FDA), according to a statement released by Regeneron Pharmaceuticals Inc.

Islaroxime receives FDA Fast Track Designation

The U.S. Food and Drug Administration (FDA) granted its Fast Track Designation to islaroxime, which is used for the treatment of acute heart failure. Islaroxime was developed by Windtree Therapeutics Inc., a biotechnology and medical device company.

FDA sends enforcement letter to Aclaris Therapeutics over Eskata advertising

The Food and Drug Administration Office of Prescription Drug Promotion recently sent a letter to Aclaris due to false or misleading claims for its direct-to-consumer advertising for Eskata.

Conference on Tobacco and Nicotine Products Regulation set for Oct. 24-25

The Tobacco and Nicotine Products Regulation and Policy Conference will take place Oct. 24-25.

FDA approves proactive-HF pivotal trial for Cordella Sensor

The multi-center PROACTIVE-HF trial of the Cordella Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor) has been approved by the Food and Drug Administration (FDA). The point of the trial is to expedite pre-market approval (PMA) of the Cordella Sensor and provide evidence to the Centers for Medicare & Medicaid Services (CMS).

FDA clears tests for new indications of Lyme disease

Diagnosing Lyme disease is notoriously difficult, so the announcement from the Food and Drug Administration (FDA) that four cleared tests with new indications are now cleared for marketing brings hope to the many who suffer from the disease.

Curaleaf receives FDA letter about CBD product marketing

The leading vertically integrated multi-state cannabis operator in the U.S. issued a statement last week about a letter it received from the Food and Drug Administration (FDA) addressing the company's CBD product marketing.

Phase 3 CANDLE study slated for Scynexis treatment of VVC

An agreement between pharmaceutical company Scynexis and the U.S. Food and Drug Administration (FDA) was reached under a special protocol assessment (SPA) on the details of the CANDLE (Conditions Affecting Neurocognitive Development and Learning in Early childhood) study for Oral Ibrexafungerp.

FDA lifts hold on phase 3 study of Venetoclax

The FDA's partial clinical hold on a phase 3 study of Venetoclax was lifted thanks to an agreement to revisions to the CANOVA study protocol.

FDA approves trial of MicroStent leg amputation device

The Food and Drug Administration gave Micro Medical approval for an Investigational Device Exemption (IDE) to start a clinical trial to investigate the safety of the MicroStent.

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).

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.

FDA Health News