FDA, AbbVie and Parkinson's
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 innovation in the space as drugmakers sought to avoid the common pitfall | The 24-hour Parkinson's disease therapy crossed the FDA finish line after an initial manufacturing-related rejection last year and another snub in June.
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 wins FDA nod for infusion treatment for advanced Parkinson’s disease
AbbVie Inc. said Thursday the Food and Drug Administration has approved its vyalev as the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson’s disease.
After delays, Abbvie wins FDA approval for Parkinson’s treatment
With two complete response letters in the rearview mirror, Abbvie Inc.’s Vyalev (foscarbidopa/foslevodopa) has been approved by the U.S. FDA for treating Parkinson’s disease. The drug is the first subcutaneous 24-hour infusion of levodopa-based therapy for treating motor fluctuations in adults with advanced disease.
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).
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.
U.S. FDA Approves VYALEV™ (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Disease
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved VYALEV™ (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy 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.
Crain's Chicago Business10h
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 Parkinson's Treatment, Medicare Coverage Expected Next Year
Vyalev (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for motor ...
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 ...
BioSpace13d
AbbVie Trims Full-Year Earnings Guidance Due to R&D Milestone Costs
While it isn’t clear what triggered the $82 million payment, the announcement comes a week after AbbVie said that its ...