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, 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.
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 ...
Commentary: FDA’s lack of vape enforcement is hurting small businesses
Thanks to the leadership of Gov. Ron DeSantis, Attorney General Ashley Moody and the Florida Legislature, a new state law to ...
Medscape11h
FDA OKs Once-Nightly Lumryz for Children with Narcolepsy
Lumryz is the only FDA-approved once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness in children ...
STAT21h
For this cancer-focused digital health startup, an FDA rejection meant the end of the road
Blue Note’s failure to clear the FDA hurdle offers a rare window into the regulatory challenges faced by digital therapeutics ...
Food Safety News4d
FDA cracks down on food importers for major safety violations
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
3 states, including Missouri and Kansas renew efforts to limit abortion pill access
The lawsuit was filed in a Texas federal court Friday, roughly four months after the Supreme Court decided against undoing ...
Cookies Recall Update as FDA Sets Highest Risk Level
According to the FDA, impacted products have best by dates ranging from September 12, 2024 to August 8, 2024. The products were sold in retail stores in Hawaii, Guam, and Las Vegas, Nevada, as well as ...
JD Supra1d
The Future of Food: Regulatory and Patent Landscape of Genome Editing in Food Technology
Our current food system is facing a myriad of critical challenges. The United Nations predicts that the world population will ...