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FDA, AbbVie and Parkinson's disease

MarketWatch · 35m

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.

Business Insider · 34m

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,

Seeking Alpha on MSN · 39m

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

MarketWatch · 48m

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.

US FDA pauses Novavax's trial of combo COVID-flu shot

MarketWatch on MSN · 45m

Novavax’s stock slides 16% after FDA puts clinical hold on COVID and flu vaccine candidates

Novavax Inc.’s stock tumbled 16% early Wednesday after the company said the FDA has placed a clinical hold on its COVID-19-and-flu combination and stand-alone flu vaccine candidates, following a case of motor neuropathy in a participant in a mid-stage trial.

US FDA pauses Novavax's trial of combo COVID-flu shot on safety concerns

The U.S. Food and Drug Administration has put Novavax's trial of an experimental COVID-flu vaccine combination on hold after one person who received the shot reported nerve damage, the company said on Wednesday.

Hosted on MSN · 22h

Novavax says FDA put hold on combination Covid-flu shot and influenza vaccine; shares plunge

The so-called clinical hold is due to a single report of nerve damage in a patient who received the combination shot in a phase two trial.

3hOpinion

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 ...

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 ...

1d

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 ...

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 ...

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 ...

The American Journal of Managed Care22h

FDA Approves Revolutionary Optune Lua Device in NSCLC

Optune Lua creates tumor treating fields to disrupt cancer cell division, and it is used in conjunction with PD-1/PD-L1 ...

KOAM News Now1d

FDA warns of Zero Sugar Minute Maid Lemonade recall

The Federal Drug Administration is warning consumers about a new recall involving a popular brand of lemonade.

Ahead of public meeting, FDA signals flexibility in evaluating smoking cessation treatments

FDA leaders said the agency was willing to consider broader endpoints in clinical trials of smoking cessation products ...

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