Tags: FDA

FDA Approves First AI-Powered Sepsis Diagnosis Tool by Prenosis

The FDA's authorization of Prenosis' AI-powered sepsis diagnostic software offers a promising solution in identifying sepsis early, potentially saving lives amidst the condition's high mortality rates.


Winrevair: Merck’s Drug for Rare, Deadly Lung Condition Gets FDA Approval

Merck has received approval from the Food and Drug Administration (FDA) for its new drug, Winrevair, designed to treat a rare and deadly lung condition.

FDA Approves First Drug to Treat Serious Liver Disease — A Win for Madrigal Pharmaceuticals as Rivals Circle

The US Food and Drug Administration (FDA) has approved Madrigal Pharmaceuticals' Rezdiffra, the first drug to treat serious liver disease.

FDA Warns Ground Cinnamon Sold at Dollar Tree and Family Dollar Contains High Levels of Lead

The US Food and Drug Administration (FDA) on Wednesday warned consumers that ground cinnamon sold by discount stores, including Dollar Tree and Family Dollar, contains high levels of lead.


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3D Communications is preeminent in preparing pharmaceutical, biotech and device companies for regulatory meetings with the FDA, EMA, and other regulatory agencies. It has just announced that it will expand its healthcare globally.
To uphold its mission and responsibility to keep US safe from any food contamination and other diseases relative thereto, United States Food and Drug Administration (FDA) recently issued revised food safety standards for state regulatory programs that oversee food facilities that manufacture, process, pack, or hold foods. These regulatory program standards also known as the Manufactured Food Regulatory Program Standards (MFRPS),
Frozen broccoli cuts have been recalled from 11 states that have been distributed with 1,800 cases which could be contaminated with Listeria monocytogenes. The infection affects young and old and can cause slight to severe infections with symptoms like high fever, abdominal pains and diarrhea to name a few aside from miscarriage and stillbirth.
Whole Foods is calling back its specialty cheese, Pecorino Aged Cheese in Walnut Leaves, that have been sold from its New York and Florida stores. The product, which tested positive for the bacterium Listeria monocytogenes, may have a fatal impact on the health of its consumers. The company has already notified its retailers and distributors and alerted its consumers of the same.
Walgreens has threatened to pull out of partnership with Theranos following the notice the latter received from the federal authorities regarding deficient medical practices. The drug retailer has given a 30-day ultimatum to its partner to clear their name, or their association gets terminated.
WHO on Thursday has warned for probable spread of Zika virus across the North and Central American countries. Ahead of rising concerns for Zika spreading, drug makers and scientists have commented that manufacturing of an appropriate vaccine may even require a decade. These warnings has opened a huge business potential for Oxitec, an Intrexon subsidiary. Oxitec’s gene modified mosquitoes are capable of ensuring security against Zika for large populations.
The FDA advisory panel has approved the use of an implant to help treat patients who are addicted to opiods. The implant will administer the drug slowly over a period of six months, but those opposed to the decision say that there are still problems with the implant that should be addressed before becoming approved for public use.
FDA has been reported to seize 90,000 bottles of RelaKzpro branded diet supplement on Wednesday. The seizure has been conducted under Federal Food, Drink & Beverage Act following a suit filed by the US Department of Justice on behalf of FDA in the District Court. The suit accuses kratom containing diet supplements as adulterated due to unreasonable health hazards.
For the first time in history, the FDA has approved the medical use of a virus to treat people with cancer - specifically those suffering from skin cancer, or melanoma. The announcement was made through a news release by the U.S. Food and Drug Administration on October 27, stating that Melanoma is the most widespread form of cancer in the country and will be responsible for the deaths of 10,000 people by the end of 2015.
General Nutrition Corporation or GNC is on the hot seat as it is being accused of selling dietary supplements incorporated with illegal additives. Along with other sellers, GNC received notification letters from the New York Attorney General's office saying that it had been unable to verify several supplements contained in the label or some ingredients are not listed in the label.
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