FDA, Parkinson's disease
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 study participants.
US FDA expands approval for Avadel's sleep disorder drug
The U.S. Food and Drug Administration has approved Avadel Pharmaceuticals' sleep disorder drug for children aged 7 years and older, broadening its use and heating up competition for widely used treatments from Jazz Pharma.
FDA Approves AbbVie's Parkinson's Disease Drug Vyalev
Thursday said that the U.S. Food and Drug Administration (FDA) has approved Vyalev for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). The approval was supported by the pivotal phase 3 study evaluating Vyalev in adults with advanced PD compared to carbidopa/levodopa,
AbbVie Gets FDA OK for Vyalev in Adults With Advanced Parkinson's Disease
AbbVie has finally won Food and Drug Administration approval of its Vyalev therapy for patients with advanced Parkinson's disease. AbbVie on Thursday said the FDA green light makes Vyalev the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with the neurodegenerative condition.
AbbVie wins FDA nod for advanced Parkinson's therapy
AbbVie (NYSE:ABBV) has received approval from the U.S. Food and Drug Administration (FDA) for Vyalev (foscarbidopa and foslevodopa) for the treatment adults with advanced Parkinson's disease. Vyalev becomes the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's
Delta Air Lines, Food and Drug Administration
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 ...
Potato Salad Recall Update as FDA Sets Highest Risk Level
The product was recalled because of undeclared soybean oil and egg, which could carry the risk of adverse health and even death.
FDA issues recalls on at least 16 food and drug items in September. Here's a list
The FDA has removed the following items from store shelves this September, including pet food, baby powder and Lactaid.
Fox News20d
New schizophrenia drug gets FDA approval, taking novel approach to treating brain disorder
On Thursday, the U.S. Food and Drug Administration (FDA) approved COBENFY (xanomeline and trospium chloride), an oral medication that is manufactured by Bristol Myers Squibb in New Jersey.
Food & Wine19d
The FDA Is Launching New Traceability Rules for Added Food Safety — and Everyone Is Confused
On January 20, 2026, the Food and Drug Administration's (FDA) new traceability rules — dubbed the Food Traceability Final Rule — will go into effect. The rule, the FDA explained, ...
NBC New York22d
FDA issues recall notices over 2 brands of pet food due to salmonella and listeria risk
Amid an ongoing pet food recall, the U.S. Food and Drug Administration (FDA) is urging pet owners not to give their ...
Investopedia20d
Bristol Myers Squibb Stock Rises After Schizophrenia Drug Gets FDA Approval
Shares of Bristol Myers Squibb (BMY) rose Friday, a day after the Food and Drug Administration (FDA) approved the use of what the pharmaceutical firm called the first treatment for ...
JD Supra9d
GLP-1 Drugs: FDA Removes Lilly’s Zepbound® and Mounjaro® (tirzepatide injection) from its Drug Shortage List
On October 2, 2024, the U.S. Food and Drug Administration (FDA) determined the shortage of the tirzepatide injection, a glucagon-like peptide ...
STAT8d
Q&A: How the FDA is approaching AI in clinical trials and drug development
The FDA's Tala Fakhouri discusses the agency's approach to the regulation of AI in clinical trials in a new interview.