FDA Clears MamaLift Plus for Postpartum Depression Treatment
Curio Digital Therapeutics receives FDA clearance for MamaLift Plus, a prescription digital therapeutic device for postpartum depression. The device, supported by the SuMMER trial, offers evidence-based therapies through a smartphone or tablet for convenient treatment.
Groundbreaking Drug Development May Extend Lifespan of Dogs
Loyal, a biotech company, is making strides in developing a drug to extend the lifespan of large-breed dogs. The FDA’s recent approval marks a significant step towards potentially increasing the longevity of our furry friends. By targeting IGF-1 signaling, the drug aims to slow down the aging process in dogs, offering hope for a future where our beloved canine companions can live longer, healthier lives.
FDA Issues High-Level Alert for Impella Left-Sided Heart Pumps
The FDA has issued a high-level alert regarding the Impella left-sided heart pumps, which have been associated with 49 deaths and 129 injuries. Despite the recall, the device will remain available on the market. Abiomed, the manufacturer of the device, has released new instructions for the pump in response to the FDA’s alert. The FDA’s notice pertains to 66,390 devices distributed in the US over a two-year period starting from October 10, 2021. This development underscores the importance of adhering to proper usage guidelines for medical devices, particularly those designed to support critical bodily functions.
FDA Approves Groundbreaking Drug for Rare Condition PAH
The FDA has approved a groundbreaking new drug for pulmonary arterial hypertension (PAH), offering hope to patients like Katrina Barry. The drug, Winrevair, developed by Merck, targets a growth factor overproduced in individuals with PAH, potentially altering the underlying biology of the disease. This represents a significant milestone in the treatment of PAH, offering new hope to patients and potentially transforming the outlook for those affected by this devastating condition.
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.