Advisory Committee – TOP DAILY NEWS

Jan152025 by adminNo Comments

FDA Panel Backs Injection for Leg Pain Caused by Herniated Discs

Pain Management > > Pain Management-- Evidence supports narrow indicator for intervertebral injections of condoliase, consultants state by Nicole Lou, Senior Staff Writer, MedPage Today January 10, 2025 FDA consultants mostly supported the regulative approval of condoliase for nerve discomfort related to back disc herniation (LDH) if it can be targeted to the ideal clients. Throughout Friday's conference of the Anesthetic and Analgesic Drug Products Advisory Committee, members voted 8-4 in assistance of the approval of condoliase, keeping in mind that the advantages of the intervertebral injection surpass t...

Apr272024 by adminNo Comments

Viagra and Alzheimer’s; Migraine Consensus Statement; FDA Updates Drug Guidance

Health and Mediacal

Neurology > > General Neurology-- News and commentary from the world of neurology and neuroscience by Judy George, Deputy Managing Editor, MedPage Today March 12, 2024 More information supported links in between the impotence drug sildenafil (Viagra) and decreased Alzheimer's danger. (Journal of Alzheimer's Disease The American Headache Society provided an agreement position declaration stating drugs targeting calcitonin gene-related peptide are a first-line choice for migraine avoidance. (Headache Eli Lilly stated the FDA will hold an advisory committee conference to go over the stage III TRAILBLAZER-ALZ 2 trial of ...

Mar22024 by adminNo Comments

United States FDA to Review Sarepta’s Duchenne Gene Therapy for Traditional Approval

Health and Mediacal

(Reuters) - Sarepta Therapeutics stated on Friday that the United States FDA would evaluate an application looking for standard approval for its gene treatment to deal with a muscle-wasting condition by June 21, months after it stopped working the primary objective of a confirmatory trial. Shares of the business increased almost 11% in early morning trading. They quickly fell in October after information from the confirmatory research study, however have actually recuperated losses ever since. The business likewise stated that the FDA did not strategy to hold a conference of its outdoors professionals to talk about the brand-new application. William Blair expert Tim Lugo stated the absence of an advisory committee conference is a favorable indication. A conventional approval represents a $...

Feb222024 by adminNo Comments

FDA Reviewers Skeptical on TriClip for Tricuspid Regurgitation

Health and Mediacal

Cardiology > > CHF-- Tricuspid valve repair work system is up for advisory committee examination on Tuesday by Nicole Lou, Senior Staff Writer, MedPage Today February 12, 2024 FDA personnel questioned the proof for medical advantage with the TriClip G4 transcatheter edge-to-edge repair work (TEER) system for serious tricuspid regurgitation (TR) in files launched ahead of the firm's Circulatory System Devices Panel conference on Tuesday. Producer Abbott has actually proposed a sign for enhancement of health status in clients with serious TR that is symptomatic regardless of ideal medical treatment and who are at inter...