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 older, broadening its use and heating up competition for widely used treatments from Jazz Pharma.
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.
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.
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 fluctuations in adults with advanced Parkinson’s disease (PD). The approval was supported by the pivotal 12-week Phase 3 study evaluating the efficacy of continuous subcutaneous infusion of Vyalev in adult patients with advanced PD compared to oral immediate-release carbidopa/levodopa (CD/LD IR),
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
Kellogg is under fire for using artificial food dyes. Here’s how they may affect your health and where else to find them
Artificial food dyes have been a hot topic over the past few years, prompting California lawmakers to propose and pass ...
Drug makers can’t make knockoff weight-loss drugs anymore—and they’re mad
With the resolution, compounding pharmacies are no longer able to produce tirzepatide. And the FDA highlighted the point to ...
STAT9d
Q&A: How the FDA is approaching AI in clinical trials and drug development
The FDA's Tala Fakhouri discusses the agency's approach to the regulation of AI in clinical trials in a new interview.
Why Ozempic, Zepbound, and other weight-loss drug dupes carry risks
Poor purity can cause patients to experience fever, chills, nausea, skin irritation, infections and low blood pressure.
Austin American-Statesman18d
FDA issues recalls on at least 16 food and drug items in September. Here's a list
This could be due to U.S. Food and Drug Administration recalls. The FDA has continued to suspend food and drug items that people might typically buy. Here is a list of September food and ...
Business Wire20d
U.S. Food and Drug Administration Approves Bristol Myers Squibb’s COBENFY™ (xanomeline and trospium chloride), a First-In-Class Muscarinic Agonist for the Treatment of ...
today announced that the U.S. Food and Drug Administration (FDA) has approved COBENFY™ (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults.
The Tribune-Democrat6dOpinion
Andrei Iancu and David Kappos | Proposed drug patent reforms would do more harm than good
Congress is considering a bill that could exacerbate government waste and give American companies’ most valuable trade ...
Today23d
FDA issues recall notices over 2 brands of pet food due to salmonella and listeria risk
Amid an ongoing pet food recall, the U.S. Food and Drug Administration (FDA) is urging pet owners not to give their dogs and cats certain food products from two different brands. Both the ...
Food and Drug Administration Celebrates the 6th Cosmetics Day
The Ministry of Food and Drug Safety held the 6th Cosmetics Day celebration with the Korea Cosmetics Association today (17th).Under the slogan "K-Cosmetics, ...
JD Supra1d
The Future of Food: Regulatory and Patent Landscape of Genome Editing in Food Technology
Our current food system is facing a myriad of critical challenges. The United Nations predicts that the world population will ...
Business Wire1mon
Papillon Therapeutics Receives Orphan Drug Designation from the U.S. Food and Drug Administration for PPL-001 for the Treatment of Friedreich's Ataxia
today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Papillon’s PPL-001, an experimental treatment for Friedreich's ataxia. “We are pleased ...
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 ...