Wegovy Approved in the US for Cardiovascular Risk Reduction in People with Overweight or Obesity and Established Cardiovascular Disease
Bagsværd, Denmark, 8 March 2024– Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved a label expansion for Wegovy based on a supplemental New Drug Application (sNDA) for the indication of reducing... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 8, 2024 Category: Drugs & Pharmacology Source Type: news

FDA warns consumers in at least 7 states not to eat mussels from parts of Newfoundland
The U.S. Food and Drug Administration on Friday advised retailers and restaurants in at least seven eastern states not to sell mussels found in parts of Newfoundland. (Source: Health News - UPI.com)
Source: Health News - UPI.com - March 8, 2024 Category: Consumer Health News Source Type: news

FDA Roundup: March 8, 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 8, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Approves Wegovy to Help Prevent Heart Attack, Stroke
FRIDAY, March 8, 2024 -- Wegovy (semaglutide), the weight-loss version of blockbuster diabetes drug Ozempic, was approved on Friday by the U.S. Food and Drug Administration to help prevent heart attack, stroke and heart death.“Wegovy is now... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - March 8, 2024 Category: General Medicine Source Type: news

‘I’m never going to be Tony’: Jeanne Marrazzo, Anthony Fauci’s successor, vows a new direction at NIAID
When Jeanne Marrazzo started her residency at the Yale New Haven Hospital in 1988, the world was a very different place. Marrazzo provided care for dying AIDS patients—mainly gay men and intravenous drug users and their sexual partners. “Stigma was alive and well and thriving, and in fact, really, really ugly at the time,” Marrazzo told an audience of young scientists on 3 March in Denver, just before the start of an HIV/AIDS conference. “You really sometimes had to work hard to get your patients what you needed. That made me interested in political and scientific advocacy and activism very early on.” At th...
Source: ScienceNOW - March 8, 2024 Category: Science Source Type: news

F.D.A. Delays Action on Closely Watched Alzheimer ’s Drug
Eli Lilly ’s donanemab was expected to be approved this month, but the agency has decided to convene a panel of independent experts to evaluate the drug’s safety and efficacy. (Source: NYT Health)
Source: NYT Health - March 8, 2024 Category: Consumer Health News Authors: Pam Belluck Tags: Drugs (Pharmaceuticals) Alzheimer ' s Disease Eli Lilly and Company Food and Drug Administration donanemab Source Type: news

In an unusual move, FDA postpones approval decision for Lilly ’s Alzheimer’s drug
The Food and Drug Administration has pushed back its approval decision deadline for Eli Lilly’s experimental Alzheimer’s drug donanemab. Lilly applied to the FDA for approval of the drug in July, after late-stage clinical trial data showed it slowed the progression of Alzheimer’s by 29% after 18…#elilillys #lilly #fda #leqembi #massachusetts #biogen #alzheimerassociation #medicare (Source: Reuters: Health)
Source: Reuters: Health - March 8, 2024 Category: Consumer Health News Source Type: news

Eli Lilly hits another Alzheimer's drug hurdle. But the main reason to own the stock remains solidly intact
Eli Lilly 's experimental Alzheimer's treatment hit another hurdle with U.S. drug regulators. It pushed out the timeline for potential approval but did not rattle our investment thesis in the company. The Food and Drug Administration plans to call a meeting of a key advisory panel to review trial…#elililly #indianapolis #lilly #fda #jimcramer #glp1 #zepbound #biogen #leqembi #eisaileqembi (Source: Reuters: Health)
Source: Reuters: Health - March 8, 2024 Category: Consumer Health News Source Type: news

A.L.S. Drug Relyvrio Fails Clinical Trial and May Be Withdrawn From the Market
Leaders of the treatment ’s manufacturer, Amylyx, said they would announce their plans for it within eight weeks. (Source: NYT Health)
Source: NYT Health - March 8, 2024 Category: Consumer Health News Authors: Pam Belluck Tags: Clinical Trials Amyotrophic Lateral Sclerosis Drugs (Pharmaceuticals) Amylyx Pharmaceuticals Inc Food and Drug Administration Cohen, Joshua B Klee, Justin United States your-feed-healthcare Source Type: news

FDA Delays Decision on New Alzheimer's Drug
FRIDAY, March 8, 2024 -- Instead of approving the new Alzheimer ' s drug donanemab this month, as was expected, the U.S. Food and Drug Administration will now require the experimental medication be scrutinized more closely by an expert panel, the... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - March 8, 2024 Category: General Medicine Source Type: news

FDA Delays Decision on New Alzheimer's Drug, Donanemab
FRIDAY, March 8, 2024 -- Instead of approving the new Alzheimer ' s drug donanemab this month, as was expected, the U.S. Food and Drug Administration will now require the experimental medication be scrutinized more closely by an expert panel, the... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - March 8, 2024 Category: General Medicine Source Type: news

FDA Warns of Elevated Lead Levels in Some Ground Cinnamon
Consumers should stop using certain cinnamon products sold by retailers including Family Dollar, Dollar Tree, and Save A Lot, due to elevated levels of lead, the Food and Drug Administration (FDA) said Wednesday in a safety alert. The warning comes following the November 2023 recall of cinnamon…#familydollar #dollartree #savealot #fda #ppm #phd #georgia #pakistan #nepal #morocco (Source: Reuters: Health)
Source: Reuters: Health - March 8, 2024 Category: Consumer Health News Source Type: news

BeiGene Announces FDA Accelerated Approval of Brukinsa for the Treatment of Relapsed or Refractory Follicular Lymphoma
BASEL, Switzerland& BEIJING& CAMBRIDGE, Mass.-- Mar 07, 2024 (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 granted... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 7, 2024 Category: Drugs & Pharmacology Source Type: news

FDA designates LSD-based drug as possible breakthrough treatment for anxiety
A psychedelic medicine biotech company announced Thursday its LSD-based drug has won U.S. Food and Drug Administration breakthrough treatment status for treating generalized anxiety disorder with lasting relief. (Source: Health News - UPI.com)
Source: Health News - UPI.com - March 7, 2024 Category: Consumer Health News Source Type: news

FDA grants accelerated approval to zanubrutinib for relapsed or refractory follicular lymphoma
On March 7, 2024, the Food and Drug Administration granted accelerated approval to zanubrutinib (Brukinsa, BeiGene USA, Inc.) with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 7, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news