AbbVie gets continuous Parkinson's drug over the line in US
AbbVie has finally claimed FDA approval for its advanced Parkinson's disease therapy Vyalev, 18 months after the US regulator turned it down with a request for more data.
After rejections, AbbVie secures approval for Parkinson’s drug
Vyalev’s clearance is the second victory for AbbVie in Parkinson’s this year, following an April readout for a drug acquired through its Cerevel buyout.
FDA Approves AbbVie's Parkinson's Treatment, Medicare Coverage Expected Next Year
The FDA approved AbbVie's Vyalev as the first 24-hour subcutaneous infusion therapy for advanced Parkinson's disease, offering improved motor control and reduced symptoms. Approval was based on a pivotal Phase 3 study.
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
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.
FDA Approves AbbVie's Parkinson's Disease Drug Vyalev
(RTTNews) - AbbVie Inc. (ABBV) 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).
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.
AbbVie’s Vyalev approved by FDA in advanced Parkinson’s disease
AbbVie announced that the FDA has approved Vyalev as the first and only subcutaneous 24-hour infusion of levodopa-based ...
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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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New AbbVie Parkinson’s drug finally gets green light to hit U.S. market
After two previous failed attempts with the FDA, AbbVie now has one more offering in its lineup — a critical step as it ...
FDA approves AbbVie’s VYALEV for advanced Parkinson’s treatment
The US Food and Drug Administration (FDA) has approved AbbVie's VYALEV (foscarbidopa and foslevodopa) to treat motor ...
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Continuous Parkinson's Disease Therapy Wins FDA Nod
"For too long, the Parkinson's community has had limited treatment options for advanced disease," Robert Hauser, MD, MBA, of ...