FDA Regulations
FDA Grants RMAT Designation to GNSC-001 for Knee Osteoarthritis Treatment
The FDA's RMAT designation for GNSC-001 highlights its potential as a groundbreaking gene therapy for knee osteoarthritis, offering long-term relief with a single injection.
Axim Biotechnologies Seeks FDA CLIA Waiver for Lactoferrin Diagnostic Test
Axim Biotechnologies has taken a significant step towards broadening access to its Lactoferrin diagnostic test by filing a Pre-Submission with the FDA for a CLIA Waiver, aiming to facilitate easier diagnosis and monitoring of Aqueous Deficient Dry Eye Disease.
United Health Products Awaits FDA Decision on Hemostatic Gauze Clinical Study
United Health Products, Inc. is in the process of addressing FDA findings related to a BIMO audit for its hemostatic gauze product, CelluSTAT, aiming to expedite patient enrollment upon approval.
SeaStar Medical Achieves Six FDA Breakthrough Device Designations, Promising New Hope for Critical Care Patients
SeaStar Medical has secured six FDA Breakthrough Device Designations for its Selective Cytopheretic Device (SCD) therapy, targeting life-threatening conditions with limited treatment options. These designations highlight the potential to transform care for patients with acute kidney injury, inflammatory responses, and other critical health challenges.