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AbbVie Gets FDA OK for Vyalev
US FDA expands approval for Avadel's sleep disorder drug
The U.S. Food and Drug Administration has approved Avadel Pharmaceuticals' sleep disorder drug for children aged 7 years and older, broadening its use and heating up competition for widely used treatments from Jazz Pharma.
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,
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.
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
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.
Novavax Stock Plunges as FDA Puts Hold on Vaccines Because of Safety Concerns
The Food and Drug Administration put clinical holds on Novavax's COVID-19 and flu combination vaccine and its standalone flu shot because of safety concerns.
Novocure, FDA and Optune Lua
Novocure shares soar 33% as FDA approves lung cancer treatment
Novocure Ltd (NASDAQ:NVCR) shares soared sharply after the announcement that the FDA had approved Optune Lua, a wearable device designed to treat certain types of lung cancer. The stock surged more than 33% in premarket
Novocure Shares Rise After FDA Approves Optune Lua Cancer Treatment
Shares of Novocure were trading higher in Tuesday's late session after the company said that the Food and Drug Administration had approved Optune Lua, its wearable treatment for certain types of lung cancer.
NovoCure’s Optune Lua Gains FDA Approval for NSCLC, Projecting Significant Sales Growth and Expansion
H.C. Wainwright analyst Emily Bodnar upgraded the rating on NovoCure (NVCR – Research Report) to a Buy today, setting a price target of
18m
on 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 ...
2h
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.
FiercePharma
47m
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 ...
STAT
6h
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 ...
Opinion
5h
Opinion
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 ...
2d
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 ...
STAT
6h
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 ...
WebMD
19h
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 ...
39m
on MSN
Cookies Recall Update as FDA Sets Highest Risk Level
More than 10,000 packages of cookies have been recalled after they were found to contain an undeclared allergen. In September ...
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