AbbVie Gets FDA OK for Vyalev
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
Novocure, FDA and Optune Lua
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 ...
AbbVie wins FDA nod for infusion treatment for advanced Parkinson’s disease
Vyalev is the first subcutaneous 24-hour continuous infusion of levodopa-based therapy for advanced Parkinson’s disease.
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 ...
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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 ...
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 ...
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3rd time's the charm: AbbVie scores FDA nod for continuous Parkinson's disease therapy Vyalev
AbbVie made history in 2015 with its Parkinson’s disease infusion pump therapy Duopa, kicking off a trend of delivery system ...
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The biggest challenge facing the FDA’s new Rare Disease Innovation Hub
Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest and a visiting ...
FDA Says Compounding Pharmacies Can Keep Making Weight-Loss Med Tirzepatide, for Now
TUESDAY, Oct. 15, 2024 (HealthDay News) -- Pharmacists may continue making compounded versions of the weight-loss medication ...
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CMR Surgical gets FDA de novo nod for Versius robot
After expanding in global markets, the U.K.-based company will challenge Intuitive Surgical in the U.S., starting with gallbladder removal procedures.
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FDA-Cleared Medical Devices Lack Proper Vetting, Doctors Say
Recalled heart devices often do not go through clinical testing, a new study found, highlighting growing concerns about the ...
FDA's promised guidance on pulse oximeters unlikely to end decades of racial bias, say experts
The patient was in his 60s, an African American man with emphysema. The oximeter placed on his fingertip registered well ...