Sequel ’s twiist™ Automated Insulin Delivery System Receives FDA 510(k) Clearance
MANCHESTER, N.H., March 18, 2024 (GLOBE NEWSWIRE) -- Sequel Med Tech, LLC, a company developing state-of-the-art insulin delivery technologies, today announced its partner, DEKA Research & Development Corp., has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the…#manchester #nh #sequelmedtech #llc #fda #aid #cgm #alanlotvin #tidepoolloop #tidepool (Source: Reuters: Health)
Source: Reuters: Health - March 19, 2024 Category: Consumer Health News Source Type: news

The Most Exciting New Advances in Managing COPD
The Global Initiative for Chronic Obstructive Lung Disease, or GOLD, is the world’s preeminent COPD research and advocacy organization. Founded in 1997 in collaboration with the U.S. National Institutes of Health and the World Health Organization, one of GOLD’s stated aims is to “improve prevention and treatment of this lung disease.” In its 2023 global strategy report, GOLD changed its definition of COPD—which many in the profession viewed as overdue. Specifically, the new definition emphasized the heterogeneity of COPD in terms of its underlying drivers and long-term disease course. [ti...
Source: TIME: Health - March 18, 2024 Category: Consumer Health News Authors: Markham Heid Tags: Uncategorized freelance Source Type: news

Attitudes toward extended-release naltrexone treatment for opioid use disorder among African Americans - Rigg KK.
BACKGROUND: Extended-release naltrexone (XR-NTX; Vivitrol ®) is a long-acting injectable form of naltrexone, which is a medication used to treat opioid use disorder (OUD). In 2010, XR-NTX received Food and Drug Administration approval to treat OUD, becoming... (Source: SafetyLit)
Source: SafetyLit - March 18, 2024 Category: International Medicine & Public Health Tags: Alcohol and Other Drugs Source Type: news

Walmart nuts RECALLED in 30 US states over potentially fatal allergies
An in-store brand of Walmart's 'honey roasted' cashews have been recalled in 30 US states and from their online retail site due to the risk of potentially fatal allergies. The US Food and Drug Administration (FDA) issued the notice Wednesday, warning consumers that 'a limited amount' of 8.25 oz…#walmart #fda #vermont #johnbsanfilipposon #squirrelbrand #southernstylenuts #jbss #upc #annalsofallergy #mayoclinic (Source: Reuters: Health)
Source: Reuters: Health - March 16, 2024 Category: Consumer Health News Source Type: news

Madrigal wins first U.S. approval for drug to treat liver disease MASH
The Food and Drug Administration on Thursday approved the first medicine developed specifically to treat the serious liver disease known as MASH. The pill, called Rezdiffra, is made by Madrigal Pharmaceuticals. Metabolic…#rezdiffra #metabolic (Source: Reuters: Health)
Source: Reuters: Health - March 16, 2024 Category: Consumer Health News Source Type: news

FDA Approves Rezdiffra for Nonalcoholic Steatohepatitis
FRIDAY, March 15, 2024 -- On Thursday, the U.S. Food and Drug Administration announced the approval of Rezdiffra (resmetirom) to treat noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate-to-advanced fibrosis. " Previously, patients with... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - March 15, 2024 Category: Pharmaceuticals Source Type: news

FDA Approves Rezdiffra, First Specific Treatment for Nonalcoholic Steatohepatitis
FRIDAY, March 15, 2024 -- On Thursday, the U.S. Food and Drug Administration announced the approval of Rezdiffra (resmetirom) to treat noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate-to-advanced fibrosis. " Previously, patients with... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - March 15, 2024 Category: Pharmaceuticals Source Type: news

Xhance Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps
YARDLEY, Pa., March 15, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the U.S. Food and Drug Administration (FDA) has... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 15, 2024 Category: Drugs & Pharmacology Source Type: news

FDA Roundup: March 15, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves first drug for common form of liver inflammation
The US Food and Drug Administration has approved the first medication for a common form of liver inflammation called nonalcoholic steatohepatitis, or NASH, the agency said Thursday. NASH — also known as metabolic dysfunction-associated steatohepatitis, or MASH — happens when the liver becomes…#nash #fda #rezdiffra #breakthroughtherapy #wayneeskridge #fattyliverfoundation #madrigal #pierregholam #universityhospitals #cleveland (Source: Reuters: Health)
Source: Reuters: Health - March 15, 2024 Category: Consumer Health News Source Type: news

FDA Approves First Drug for Common, Serious Liver Disease, Rezdiffra
FRIDAY, March 15, 2024 -- Millions of Americans whose livers develop scar tissue due to a common disease now have the first approved drug, Rezdiffra, to treat the condition, the U.S. Food and Drug Administration announced Thursday. The condition is... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - March 15, 2024 Category: General Medicine Source Type: news

Clarity reports on third cohort in copper theranostic trial
Clarity Pharmaceuticals has completed its third cohort in the theranostic SECuRE trial evaluating copper-64 (Cu-64) and copper-67 (Cu-67) sarcophagine chelator technology in patients with metastatic castration-resistant prostate cancer. In this phase I/IIa trial of Cu-64 for the diagnostic and Cu-67 for the therapeutic, the company noted no dose-limiting toxicities in cohort 3, and an overall safety review of all cohorts 1, 2, and 3 also showed favorable safety profiles. Cohort 3 participants had the highest number of pretreatments prior to entering the study across all cohorts, with most patients receiving five or more l...
Source: AuntMinnie.com Headlines - March 15, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Nuclear Radiology Radiation Oncology Source Type: news

Robotic Surgery Giant Wins FDA OK For Next-Gen System; Shares Pop
stock jumped late Thursday after the company won Food and Drug Administration clearance for its next-generation robotic surgery system, da Vinci 5. Chief Executive Gary Guthart says its next-gen robot will provide "meaningful improvements in surgery that enable better patient outcomes, enhance the…#davinci5 #garyguthart #intuitivesurgical #davincixi #allisongatlin #ibdagatlin #buyzone (Source: Reuters: Health)
Source: Reuters: Health - March 15, 2024 Category: Consumer Health News Source Type: news

FDA Approves Tevimbra (tislelizumab-jsgr) for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma
BASEL, Switzerland& BEIJING& CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 14, 2024 Category: Drugs & Pharmacology Source Type: news

Geron's Blood Disorder Drug Gets FDA Advisers' Backing Geron's Blood Disorder Drug Gets FDA Advisers' Backing
Advisers to the U.S. Food and Drug Administration on Thursday backed benefits of Geron ' s blood disorder drug, saying it outweighed the risks associated with the treatment,...Reuters Health Information (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - March 14, 2024 Category: Cancer & Oncology Tags: Hematology-Oncology Source Type: news