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CDC to investigate ‘safety signal’ for Pfizer’s updated COVID booster
Federal health officials are investigating whether there is a link between BioNTech BNTX, and Pfizer’s PFE, bivalent COVID-19 booster and stroke in seniors. The Centers and Disease Control and Prevention and the Food and Drug Administration said Friday they plan to investigate a…#veteransaffairs #medicaidservices #pfizers #fda #vsd #cdc #vaccines #modernasmrna #medicare #bntx
Source: Reuters: Health - January 17, 2023 Category: Consumer Health News Source Type: news

AstraZeneca's heart drug gets FDA nod
AstraZeneca Plc said on Monday the U.S. Food and Drug Administration has approved its drug for reducing the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.
Source: Reuters: Health - June 1, 2020 Category: Consumer Health News Tags: healthNews Source Type: news

FDA approves expanded label for Regeneron/Sanofi's cholesterol drug
The U.S. Food and Drug Administration on Friday approved Regeneron Pharmaceuticals Inc's cholesterol drug Praluent as a treatment to cut the risk of heart attacks, stroke and other major cardiovascular events.
Source: Reuters: Health - April 27, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

FDA clears Novo Nordisk's diabetes drug to reduce cardiovascular risk
(Reuters) - Novo Nordisk said on Friday the U.S. Food and Drug Administration (FDA) approved an expanded use of its diabetes drug to reduce the risk of cardiovascular events such as heart attack and stroke.
Source: Reuters: Health - August 25, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

FDA rejects Eagle Pharmaceuticals' heat stroke treatment
(Reuters) - Eagle Pharmaceuticals Inc said on Tuesday the U.S. Food and Drug Administration declined to approve its drug Ryanodex to treat heat stroke and requested an additional clinical trial.
Source: Reuters: Health - July 26, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

FDA strengthens warning label for certain anti-inflammatory drugs
(Reuters) - The U.S. food and Drug Administration said it was strengthening an existing warning label that non-aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke.
Source: Reuters: Health - July 10, 2015 Category: Consumer Health News Tags: healthNews Source Type: news

Boston Scientific gets U.S. OK for Watchman heart device
(Reuters) - Boston Scientific Corp said on Friday that the U.S. Food and Drug Administration approved its device to prevent stroke in patients with a dangerous irregular heart rhythm known as atrial fibrillation (AF).
Source: Reuters: Health - March 13, 2015 Category: Consumer Health News Tags: healthNews Source Type: news

FDA panel backs Daiichi's blood thinner
(Reuters) - A panel of advisers to the U.S. Food and Drug Administration voted 9-1 in favor of approving Japanese drugmaker Daiichi Sankyo Co's blood clot and stroke preventer for use in some patients with atrial fibrillation.
Source: Reuters: Health - October 30, 2014 Category: Consumer Health News Tags: healthNews Source Type: news

FDA panel offers mixed view on Boston Scientific Watchman device
WASHINGTON (Reuters) - An advisory panel to the U.S. Food and Drug Administration offered a mixed view of Boston Scientific Corp's Watchman heart device on Wednesday, concluding it is probably safe but not particularly effective in reducing the risk of stroke in patients with a certain type of irregular heart beat.
Source: Reuters: Health - October 8, 2014 Category: Consumer Health News Tags: healthNews Source Type: news

FDA says asthma drug Xolair raises risk of heart, brain problems
WASHINGTON (Reuters) - The asthma drug Xolair is associated with a higher risk of heart attack, mini-stroke, chest pain and blood clots in the lungs and veins, among other problems, though the extent of increased risk is unclear, the U.S. Food and Drug Administration said on Friday.
Source: Reuters: Health - September 26, 2014 Category: Consumer Health News Tags: healthNews Source Type: news

FDA looks again at Boston Scientific anti-stroke device
(Reuters) - U.S. Food and Drug Administration staff reviewing data on Boston Scientific Corp's novel anti-stroke device highlighted the implant's failure to meet a key goal for effectiveness in a recent study but said on Monday that other data must be weighed in deciding whether it should be approved.
Source: Reuters: Health - December 9, 2013 Category: Consumer Health News Tags: healthNews Source Type: news

FDA says new cholesterol drugs may not need outcome studies
(Reuters) - Members of an experimental class of cholesterol-lowering drugs could get U.S. regulatory approval based on their ability to lower "bad" cholesterol, and may not need to show that they reduce the risk of heart attack and stroke, the Food and Drug Administration said on Thursday.
Source: Reuters: Health - November 15, 2013 Category: Consumer Health News Tags: healthNews Source Type: news