JD Supra4d
Finally, FDA’s Final Word on Unapproved Use Communications
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...
BioPharma Dive14d
FDA clears use of Ozempic to protect kidney health
The approval adds a new indication for GLP-1 drugs and gives Novo an advantage over Lilly’s rival diabetes drug Mounjaro, ...
JD Supra1d
FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU) Communications
FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding ...
FDA clears sepsis test that significantly reduces life-or-death diagnosis time
Sepsis, a life-threatening organ dysfunction, is responsible for an estimated 1 in 5 deaths globally and 1 in 3 deaths that occur within a U.S. hospital. It happens due to a dysregulated immune ...
FDA clears migraine device for children as young as 8
A device long used by adults to manage migraines was now available for children as young as eight years old, offering new ...
Pharmabiz25d
US FDA clears expanded use of Alcresta Therapeutics’ RELiZORB cartridge for paediatric patients 1 year of age and older
announced that the US Food and Drug Administration (FDA) has cleared expanded use of RELiZORB for children down to age 1 year old. RELiZORB is a digestive enzyme cartridge designed to mimic the ...
Firefly Neuroscience Accepted into NVIDIA Connect Program
Collaboration to provide Firefly with the technical resources to help further unleash the power of its FDA-cleared BNA™ platform For the ...
Hosted on MSN15d
FDA grants 510(k) clearance for Imperative Care’s stroke thrombectomy system
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Imperative Care’s Zoom System, marking an advancement in stroke thrombectomy procedures. The clearance marks it as the first ...
Miamisburg-based Riverain Technologies receives FDA clearance for AI-powered imaging software
A Dayton-area medical technology firm has recently had its AI-driven image processing and analysis technology cleared by the ...
pharmaphorum8d
GSK's Boostrix for pertussis cleared by FDA for use in pregnancy
The FDA has approved use of GlaxoSmithKline’s Boostrix (Tdap) vaccine for use during the third trimester of pregnancy, for prevention of pertussis (whooping cough) in infants younger than two ...