HI-Bio™ Receives Orphan Drug Designation for Felzartamab Targeted Therapy
HI-Bio™ has received Orphan Drug Designation from the FDA for felzartamab, a targeted therapy for antibody-mediated rejection in kidney transplant recipients. This designation is a significant milestone in addressing the critical unmet medical need for AMR, with potential breakthrough implications. The Orphan Drug Designation qualifies HI-Bio for certain development incentives, expected to accelerate the development of felzartamab and enhance the company’s ability to bring this innovative therapy to patients in need.
Intuitive Surgical, Inc. Receives FDA Clearance for da Vinci 5 Robotic System
Intuitive Surgical, Inc. has received FDA clearance for its latest product, the da Vinci 5, a multiport robotic system with over 150 improvements. The system features improved accuracy, next-generation 3D display, Force Feedback technology, and advanced computing power. Initially available to select U.S. customers, the da Vinci 5 aims to enhance minimally invasive surgery and improve operating room efficiency.
FDA Approves First Medication for Liver Inflammation NASH
The US FDA has approved the first medication for nonalcoholic steatohepatitis (NASH), a liver inflammation condition affecting millions. The medication, Rezdiffra, developed by Madrigal Pharmaceuticals, offers a groundbreaking solution for moderate to advanced fibrosis resulting from NASH. Clinical trials showed promising outcomes, with over 25% of participants achieving NASH resolution without fibrosis worsening. However, the medication may have significant interactions with certain other drugs, and a post-approval study is needed to verify its clinical benefits.
FDA approves Novo Nordisk’s weight loss drug Wegovy for reducing cardiovascular risk
The FDA has approved Novo Nordisk’s weight loss drug, Wegovy, for reducing the risk of serious cardiovascular complications in adults with obesity and heart disease. This could expand insurance coverage for the drug, addressing a major barrier to patient access. Wegovy has been shown to reduce the overall risk of heart attack, stroke, and cardiovascular-related death by 20%, marking a significant milestone in public health for adults with obesity and heart disease.
Recall issued for chili-flavored sauce over toxin concerns
A recall was issued for a chili-flavored sauce over concerns of contamination with toxins. The FDA announced the voluntary recall by Aji Mori Sauce Corp., DBA Sushi Koo, due to lack of oversight. The sauce was distributed in Los Angeles, California, and sold online. No illnesses have been reported. The recall offers full refunds for the product.
High Levels of Cancer-Causing Chemical Found in Acne Treatment Products
High levels of benzene, a cancer-causing chemical, have been found in popular acne treatment products, prompting a petition to the FDA for product recall and further investigation. Benzene is a known carcinogen and prolonged exposure can have severe health effects, including anemia and blood cancers. This discovery raises concerns about the safety and regulation of consumer goods, highlighting the need for stricter oversight of potentially harmful chemicals in skincare and personal care items.
Zimmer Biomet Receives FDA Clearance for Rosa Robotic-Assisted Total Shoulder Replacement System
Zimmer Biomet has received FDA 510(k) clearance for its Rosa robotic-assisted total shoulder replacement system, a significant advancement in orthopedic surgery. The system, designed for anatomic or reverse total shoulder replacement, is the latest addition to the company’s Rosa robotics portfolio. The Rosa shoulder system is set to be commercially available in the U.S. in the second half of 2024.
FDA Approves Omalizumab for Reduction of Allergic Reactions in Patients with Food Allergies
FDA approves omalizumab (Xolair; Novartis) as the first and only medicine to reduce allergic reactions in patients with food allergies. The drug is not for emergency treatment and patients should continue avoiding allergenic foods. Positive results from the phase 3 OUtMATCH study show potential for omalizumab to mitigate allergic reactions in patients with multiple food allergies.
FDA Concludes Investigation into Listeria Outbreak Linked to Recalled Fruit
The FDA has concluded its investigation into a Listeria outbreak linked to conventionally grown peaches, plums, and nectarines that were voluntarily recalled by HMC Farms. The outbreak resulted in 11 illnesses, 10 hospitalizations, and one fatality across seven states. The conclusion of the investigation provides important insights for food safety measures and regulations.
Montelukast (Singulair) Linked to Serious Mental Health Risks, Especially in Children
In a recent study, it has been discovered that the popular asthma and allergy drug montelukast, also known as Singulair, can potentially cause serious mental health risks, especially in children. Despite these alarming findings, the drug continues to be widely…