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
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 ...
FDA issues recalls on at least 16 food and drug items in September. Here's a list
The FDA has removed the following items from store shelves this September, including pet food, baby powder and Lactaid.
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.
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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.
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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 ...
JD Supra10d
GLP-1 Drugs: FDA Removes Lilly’s Zepbound® and Mounjaro® (tirzepatide injection) from its Drug Shortage List
On October 2, 2024, the U.S. Food and Drug Administration (FDA) determined the shortage of the tirzepatide injection, a glucagon-like peptide ...
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, ...
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 ...
JD Supra2d
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 ...
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10 careers in food science: Driving innovation and sustainability in the food industry
Careers in food science not only focus on improving food quality but also on addressing challenges like food security, waste ...
Drug companies that violate law would fund medical research under new Democratic legislation
Sen. Elizabeth Warren (D-Mass.) and Rep. Jan Schakowsky (D-Ill.) have introduced legislation that would require ...