Food and Drug Administration (FDA) News This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

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

A Blood Test for Colon Cancer Shows Promise
A blood test for colon cancer performed well in a study published Wednesday, offering a new kind of screening for a leading cause of cancer deaths. The test looks for DNA fragments shed by tumor cells and precancerous growths. It’s already for sale in the U.S. for $895, but has not been approved by the Food and Drug Administration and most insurers do not cover it. The maker of the test, Guardant Health, anticipates an FDA decision this year. [time-brightcove not-tgx=”true”] In the study, the test caught 83% of the cancers but very few of the precancerous growths found by colonoscopy, the gold stan...
Source: TIME: Health - March 14, 2024 Category: Consumer Health News Authors: Carla K. Johnson/AP Tags: Uncategorized healthscienceclimate wire Source Type: news

U.S. FDA Approves Bristol Myers Squibb ’s Breyanzi as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
PRINCETON, N.J.--(BUSINESS WIRE) Mar 14, 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 14, 2024 Category: Drugs & Pharmacology Source Type: news

U.S. Food and Drug Administration (FDA) Has Accepted the New Drug Application (NDA) for Ensartinib
MIAMI--(BUSINESS WIRE) March 13, 2024 --Xcovery Holdings, Inc., an oncology focused pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ensartinib, an Anaplastic... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 13, 2024 Category: Drugs & Pharmacology Source Type: news

US FDA Approves Expanded Use Of Mirum's Liver Disease Drug US FDA Approves Expanded Use Of Mirum's Liver Disease Drug
The U.S Food and Drug Administration has approved the expanded use of Mirum Pharmaceuticals ' oral drug to treat itching caused by a liver disorder in patients aged five...Reuters Health Information (Source: Medscape Gastroenterology Headlines)
Source: Medscape Gastroenterology Headlines - March 13, 2024 Category: Gastroenterology Tags: Gastroenterology Source Type: news

Govvi WOW! contains hidden ingredients
The Food and Drug Administration is advising consumers not to purchase or use Govvi WOW!, a product promoted and sold for weight loss on various websites, including www.ebay.com and possibly in some retail stores. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 13, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news