food and drug administration fda news

AbbVie Gets FDA OK for Vyalev

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.

Business Insider · 11h

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,

MarketWatch · 11h

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.

Seeking Alpha on MSN · 11h

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

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

Reuters · 1d

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.

Barron's on MSN · 16h

Novavax Stock Plummets as FDA Pauses Clinical Trial on Safety Concerns

Novavax stock fell sharply Wednesday after the U.S. Food and Drug Administration halted one of the vaccine maker’s clinical trials, citing safety concerns.Shares plummeted 18% to $10.32 in midday trading.

Axios on MSN · 1d

FDA halts trial of Novavax COVID-flu combo shot

The Food and Drug Administration halted Novavax's trial of a combination vaccine for COVID and influenza, as well as a standalone flu shot, after a participant suffered a serious adverse event, the company said on Wednesday.

8hon MSN

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 ...

7hon MSN

Potato Salad Recall Update as FDA Sets Highest Risk Level

The product was recalled because of undeclared soybean oil and egg, which could carry the risk of adverse health and even death.

3don 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 ...

Medscape5h

FDA OKs Once-Nightly Lumryz for Children with Narcolepsy

Lumryz is the only FDA-approved once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness in children ...

10hon MSN

Arthritis and Joint Pain Supplements Recalled Due to Undeclared Drugs

Tablets labeled as dietary supplements for joint pain and arthritis are being recalled after the FDA found three undeclared ...

13h

Recent recalls raise concerns about food safety, but experts credit better regulation and technology

According to FDA data, nearly 1,200 food products have been recalled so far in 2024. Two hundred products were recalled in ...

STAT14h

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 ...

14hOpinion

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 ...

3hon MSN

3 states, including Missouri and Kansas renew efforts to limit abortion pill access

The lawsuit was filed in a Texas federal court Friday, roughly four months after the Supreme Court decided against undoing ...

STAT14h

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 ...

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