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Management: Food and Drug Administration (FDA)

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Total 5166 results found since Jan 2013.

Doctors group petitions FDA to require ED drug labels recommend plant-based diet
(Physicians Committee for Responsible Medicine) Package labels for Viagra, Cialis, and other erectile dysfunction (ED) drugs should inform patients that ED is a sign of potentially fatal artery disease, according to a petition the Physicians Committee for Responsible Medicine filed with the Food and Drug Administration on Feb. 10, 2020.
Source: EurekAlert! - Medicine and Health - February 10, 2020 Category: International Medicine & Public Health Source Type: news

CAR-T therapy for lymphoma studied at UNC Lineberger receives FDA fast-track designation
(UNC Lineberger Comprehensive Cancer Center) Based on proof-of-concept results from clinical trials at University of North Carolina Lineberger Comprehensive Cancer Center and Baylor College of Medicine, an investigational cellular immunotherapy for Hodgkin lymphoma has received a Regenerative Medicine Advanced Therapy designation from the U.S. Food and Drug Administration.
Source: EurekAlert! - Medicine and Health - March 9, 2020 Category: International Medicine & Public Health Source Type: news

To Improve Public Health, Medicine Regulators Worldwide Should Collaborate, Remove Barriers to Sharing Information, Says New Report
Medicine regulatory authorities — including the U.S. Food and Drug Administration (FDA) — should strengthen cooperation with other countries’ regulators to ensure the quality, safety, and efficacy of medicines, says a new report from the National Academies of Sciences, Engineering, and Medicine.
Source: News from the National Academies - November 21, 2019 Category: Science Source Type: news

The plague of unexpected drug recalls and the pandemic of falsified medications in cardiovascular medicine as a threat to patient safety and global public health: A brief review.
Abstract Valsartan, losartan, and irbesartan, are widely used in the treatment strategies of cardiovascular medicine diseases, including hypertension and heart failure. Recently, many formulations for the aforementioned diseases contained active pharmaceutical ingredients and had been abruptly recalled from the market due to safety concerns mainly associated with unwanted impurities - nitrosamines, which are highly carcinogenic substances accidentally produced during manufacturing. Along with cardiovascular medications, formulations containing ranitidine were also recalled from the market. This poses a particular ...
Source: Cardiology Journal - December 21, 2020 Category: Cardiology Authors: Świeczkowski D, Zdanowski S, Merks P, Szarpak Ł, Vaillancourt R, Jaguszewski MJ Tags: Cardiol J Source Type: research

Observation of the Expression of Vascular Endothelial Growth Factor and the Potential Effect of Promoting Hair Growth Treated with Chinese Herbal BeauTop
Evid Based Complement Alternat Med. 2021 Feb 17;2021:6667011. doi: 10.1155/2021/6667011. eCollection 2021.ABSTRACTDespite minoxidil and finasteride already being approved by the Food and Drug Administration (FDA) for the treatment of hair loss, it is important to identify new and innovative treatments for hair loss, such as looking for a solution in Chinese herbal medicine. One such treatment to consider is BeauTop (BT), whose primary ingredients include Panax japonicus (T.Nees), C.A. Mey. (Araliaceae), Astragalus membranaceus (Fisch) Bunge (Fabaceae), Angelica sinensis (Oliv.) Diels (Apiaceae), Ligustrum lucidum W.T. Aito...
Source: Evidence-based Complementary and Alternative Medicine - March 8, 2021 Category: Complementary Medicine Authors: Chien-Ying Lee Chun-Hung Su Chien-Ying Chiang Chun-Nan Wu Yu-Hsiang Kuan Source Type: research

Data for Roche ’s Evrysdi® (risdiplam) published in New England Journal of Medicine shows significant improvement in survival and motor milestones in babies with Type 1 spinal muscular atrophy (SMA)
Basel, 29 July 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the New England Journal of Medicine (NEJM) has published data from FIREFISH Part 2, a pivotal global study evaluating the efficacy and safety of Evrysdi® (risdiplam) in babies aged 1-7 months old with symptomatic Type 1 spinal muscular atr ophy (SMA). The study met its primary endpoint with 29% of infants (12/41) sitting without support for at least five seconds* by month 12, a milestone not seen in the natural course of the disease. Safety for Evrysdi in the FIREFISH Part 2 study was consistent with its known safety profile.“Without treatme...
Source: Roche Media News - July 29, 2021 Category: Pharmaceuticals Source Type: news

The Novel Chinese Medicine JY5 Formula Alleviates Hepatic Fibrosis by Inhibiting the Notch Signaling Pathway
In this study, we found a novel JY5 formula, which exerted anti-hepatic fibrotic effects by inhibiting the Notch signaling pathway, consequently suppressing HSCs activation. These results provide an adequate scientific basis for clinical research and application of the JY5 formula, which may be a potential novel therapeutic candidate for liver fibrosis.
Source: Frontiers in Pharmacology - September 22, 2021 Category: Drugs & Pharmacology Source Type: research

To Improve Public Health, Medicine Regulators Worldwide Should Collaborate, Remove Barriers to Sharing Information, Says New Report
Medicine regulatory authorities — including the U.S. Food and Drug Administration (FDA) — should strengthen cooperation with other countries’ regulators to ensure the quality, safety, and efficacy of medicines, says a new report from the National Academies of Sciences, Engineering, and Medicine.
Source: News from the National Academies - November 21, 2019 Category: Science Source Type: news

Applying Pharmacogenomic Guidelines to Combat Medical Care
We present potential applications of pharmacogenomics to forward medical care through two comprehensive references for deployed medical care, the Tactical Combat Casualty Care Guidelines (TCCC) and Emergency War Surgery (EWS) fifth edition. All drugs within the deployment manuals, TCCC guidelines and EWS book, were identified and the list was cross-referenced to the Clinical Pharmacogenetics Implementation Consortium guidelines and genes-drugs interactions list as well as the Food and Drug Administration Table of Pharmacogenomics Biomarkers in Drug Labeling. Ten pharmacologic categories were identified, consisting of 15 dr...
Source: Military Medicine - December 30, 2021 Category: International Medicine & Public Health Authors: Jesse DeLuca Thomas Oliver Chad Hulsopple Daniel Selig Elaine Por Clesson Turner Lydia Hellwig Jeffrey Livezey Source Type: research