FDA Escalates Recall of Inspire Medical’s Nerve-Stimulating Implant for Sleep Apnea
The FDA has issued a Class I recall for Inspire Medical’s nerve-stimulating implant used in treating obstructive sleep apnea due to a manufacturing defect. Despite no reported injuries, up to 32 devices may be impacted. Inspire Medical continues to expand its therapy offerings amidst the recall, with a projected revenue growth of 26% for 2024.
FDA Authorizes Cepheid’s Molecular Test for Hepatitis C Detection from Fingerstick Blood Samples
Cepheid has received de novo authorization from the FDA for a molecular test that can detect hepatitis C virus RNA directly from fingerstick blood samples, revolutionizing the healthcare industry. The Xpert HCV test, running on Cepheid’s Genexpert Xpress System, provides rapid results within one hour, eliminating the need for samples to be sent to central labs. This game-changing approval enables same-visit diagnosis and treatment, potentially increasing the number of hepatitis C patients being diagnosed and treated promptly.
FDA Approves Eli Lilly’s Alzheimer’s Drug Donanemab
The FDA has approved Eli Lilly’s Alzheimer’s drug donanemab, now marketed as Kisunla, offering hope to the 7 million Americans affected by the disease. Donanemab targets toxic plaques in the brain to slow disease progression, competing with Biogen and Eisai’s Leqembi. Clinical trials showed a 35% reduction in Alzheimer’s progression over 18 months, with monthly infusions costing $12,522 for a six-month course.
CDC Recommends Covid-19 Vaccines for All Americans This Fall
CDC recommends all Americans ages 6 months and older receive new Covid-19 vaccines this fall as infections rise in 39 states. Vaccines offer incremental boost to waning immunity against evolving virus. Panel advises another round of immunizations to protect against current strains.
Bavarian Nordic Submits Chikungunya Vaccine for Approval in Europe
Bavarian Nordic has submitted its chikungunya vaccine for approval in Europe, following a similar application in the US. This strategic move aims to combat the spread of the mosquito-borne viral disease and improve global health initiatives. Stay tuned for updates on the potential approval in the first half of 2025.
Groundbreaking Discovery in Parkinson’s Disease Research
Groundbreaking research on Parkinson’s disease reveals potential FDA-approved treatment targeting cell surface protein Aplp1 and Lag3 to block spread of harmful material. Findings suggest promising therapy avenue already available, offering hope to millions worldwide.
FDA Approves First Menthol E-Cigarettes for Adult Sale
The FDA has approved the sale of the first menthol e-cigarettes for adults, recognizing their potential health benefits in reducing traditional cigarette smoking effects. Despite concerns, NJOY Holdings’ products have received authorization, but it’s crucial to note that FDA approval doesn’t mean they’re completely safe. With 27 approved products, the FDA is reviewing the vaping industry. While some criticize the decision, the FDA lifted marketing restrictions on Juul e-cigarettes and the Biden administration delayed a menthol tobacco ban. The approval of menthol e-cigarettes highlights the changing landscape of smoking cessation methods and regulations in the U.S.
FDA Approves New Drug Iqirvo for Autoimmune Liver Disease Treatment
The FDA has approved a new drug, Iqirvo (elafibranor), for treating autoimmune liver disease, specifically primary biliary cholangitis (PBC). PBC can lead to liver damage or failure if left untreated, making early detection crucial. Iqirvo offers a targeted therapeutic approach to manage PBC and prevent complications, marking a significant advancement in autoimmune liver disease treatment.
FDA Classifies Cookie Dough Recall Due to Salmonella Concerns
Nearly 30,000 batches of cookie dough have been recalled due to potential salmonella contamination, prompting the FDA to elevate the risk classification to Class II. The affected products include popular brands like Costco Chocolate Chunk and Panera Chocolate Chipper. Consumers are urged to check for specific lot codes and avoid consuming the recalled items to prevent food poisoning.
FDA Recalls 28 Beverages in 2024 Due to Undisclosed Drugs, Bacteria, and Chemicals
The FDA has recalled 28 beverages in 2024 due to undisclosed drugs, bacteria, and harmful chemicals. From arsenic in Martinelli’s Apple Juice to bacteria in Fiji Water, consumers are urged to be cautious. Stay informed on the latest recalls including Schweppes Zero Sugar Gingerale and PepsiCo’s Mug Root Beer.