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FDA, AbbVie and Parkinson's disease

MarketWatch · 32m

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 · 31m

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 · 36m

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 · 45m

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 · 42m

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.

The Wall Street Journal on MSN · 22h

Novavax Says FDA Puts Clinical Hold on Covid-19, Flu Vaccines

Novavax said federal regulators put a clinical hold on its application for a combination Covid-19 and influenza vaccine and standalone flu inoculation, sending shares down sharply.

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 ...

2don MSN

FDA will reconsider decision barring copycat versions of Lilly weight loss drug

The Food and Drug Administration (FDA) said it will reconsider its decision to remove Eli Lilly’s blockbuster weight loss and ...

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 ...

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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