FDA asks Texas court to shut down COVID-19 vaccine records lawsuit
The U.S. Food and Drug Administration has asked a federal judge in Texas to throw out a public records lawsuit related to ...
Business Times32m
FDA approves Astellas’ gastric cancer therapy
THE US Food and Drug Administration (FDA) approved Astellas’ therapy to treat a type of gastric cancer, the health ...
Ice Cream Recall Update As FDA Sets Risk Level Over Undeclared Ingredients
The U.S. Food and Drug Administration ( FDA) has classified the recall of a brand of ice cream as Class II after it was discovered that the product contained undeclared food colorings Yellow 5 ...
Intercept’s liver disease drug Ocaliva faces FDA approval delay
An FDA AdCom in September recommended against full approval for Ocaliva by a 13-1 vote for the treatment of primary biliary ...
Medscape8h
FDA OKs Novel Levodopa-Based Continuous Sub-Q Regimen for Parkinson’s
Vyalev (AbbVie) is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy to address motor fluctuations in advanced Parkinson’s disease.
US FDA expands use of Avadel's sleep disorder drug to ages 7 and up
The U.S. Food and Drug Administration has approved Avadel Pharmaceuticals' sleep disorder drug for children aged 7 years and ...
Injectable drug to ease advanced Parkinson's disease symptoms approved by FDA
The FDA on Thursday approved an injectable drug that eased Parkinson's disease symptoms and improved motor fluctuations in ...
Nationwide Antidepressant Recall Update As FDA Sets Risk Class
On October 11, the recall was classified as a class II recall by the FDA—a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health ...
thehealthy1h
785,000 Diabetes Devices Have Been Recalled Nationwide and in Puerto Rico
You're not able to count on it for as long as expected, say experts who call the risk high. Here's who's affected—possibly ...
Recent recalls raise concerns about food safety, but experts credit better regulation and technology
According to FDA data, nearly 1,200 food products have been recalled so far in 2024. Two hundred products were recalled in ...
Medscape7h
FDA OKs Zolbetuximab for Gastric, Gastroesophageal Cancer
FDA also approved the Ventana CLDN18 (43-14A) RxDx Assay, from Ventana Medical Systems, Inc. and Roche Diagnostics, to ...
STAT7d
In stark reversal, FDA to reconsider removal of Eli Lilly weight loss drug from shortage list
The FDA, in a stark reversal, on Friday said it would reconsider its decision to remove Eli Lilly’s tirzepatide from its ...