Regulatory Experts Share Exclusive Article
The health subcommittee of the House Energy and Commerce (E&C) Committee is set to hold a markup this week for the proposed Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization. However, the Food and Drug Administration (FDA) is facing a setback, as none of its legislative requests will be met in the new bill. The PAHPA […]
First Nonprescription Daily Oral Contraceptive Receives FDA Approval
The U.S. Food and Drug Administration (FDA) has approved Opill, a non-prescription oral contraceptive tablet, for preventing pregnancy. This is the first daily oral contraceptive that can be purchased without a prescription in the United States. Opill will be available for sale at drug stores, convenience stores, grocery stores, and online, but the availability and […]
MobiHealthNews reports on Wellinks’ appointment of a new CEO
Wellinks, a company specializing in digital solutions for chronic obstructive pulmonary disease (COPD), has appointed Stacie Bratcher as its new CEO. Bratcher has previously served as CEO of Jet Health and Alana Healthcare, as well as holding the position of board chair at GripAble. In her new role, Bratcher aims to leverage virtual solutions to […]
Startup Français obtient 14 millions de dollars pour son outil d’intelligence artificielle d’échographie prénatale
French medical technology startup, Sonio, has raised $14 million in Series A funding, bringing its total funding to $20 million since its founding in 2020. Sonio’s AI platform automates ultrasound reporting, aiming to improve accuracy, speed, and efficiency for healthcare providers. The platform receives ultrasound images from any machine and processes them in the cloud […]
Preparing for New Alzheimer’s Treatments: Three Essential Steps Health Systems Must Take
The number of Americans affected by Alzheimer’s disease is on the rise, especially as Baby Boomers reach the age of 65. However, the lack of effective drug therapies and limited screening for cognitive decline have hindered a response to this public health crisis. Recently approved FDA drugs offer promising treatment options for Alzheimer’s, but they […]
FDA Approves Better Therapeutics’ Mobile App as Treatment for Type 2 Diabetes
The FDA has authorized a mobile app called AspyreRx, developed by Better Therapeutics, as a treatment for type 2 diabetes. This regulatory decision creates a new class of therapies for the metabolic disorder. AspyreRx is a prescription digital therapeutic that digitizes cognitive behavioral therapy, which is already part of diabetes care. The app allows patients […]
FDA Updates: July 11, 2023
The U.S. Food and Drug Administration (FDA) has provided an update on various activities happening within the agency. One of the main focuses is the prevention of illicit xylazine from entering the United States. The FDA’s Center for Veterinary Medicine (CVM) is working in collaboration with other FDA offices and the Department of Health and […]
Septerna Secures $150M Financing Led by RA Capital for Groundbreaking Oral Edge Drug in Rare Hormone Disease
Septerna Therapeutics has secured $150 million in Series B financing to support the development of its small molecule drug candidate for the treatment of hypoparathyroidism. The funding round was led by RA Capital Management and included participation from a range of investors, including Deep Track Capital, Goldman Sachs Asset Management, and Vertex Ventures HC, among […]
FourPlus, an immersive tech company, secures funding to develop a cutting-edge mixed reality platform.
UK-based immersive technology company FourPlus has secured funding from Innovate UK, the UK’s national innovation agency, to develop a mixed reality training platform for pharmaceutical companies and the healthcare sector. FourPlus already uses its immersive technology, including virtual reality experiences, in the life sciences sector for marketing, training, and workforce management. With a ₤1 million […]
First Cell Therapy for Type 1 Diabetes Receives FDA Approval, Made Possible by Startup’s Success
CellTrans, a small biotech company, has received the first FDA approval for a cell therapy for type 1 diabetes. The therapy, known as Lantidra, is intended for adults with type 1 diabetes who are unable to achieve their target blood glucose levels through regular insulin administration. Lantidra, which is made from pancreatic cells sourced from […]