US FDA approves Amgen's colorectal cancer therapy
The U.S. Food and Drug Administration approved Amgen's combination therapy on Thursday to treat colorectal cancer in patients ...
MassDevice4d
The top 10 cardiac device stories of 2024
Cardiac device innovations made waves in 2024, with regulatory approvals, clinical breakthroughs, and product launches ...
The Best Red Light Therapy Devices & How to Safely Use Them, According to Editors & Experts
The World’s Strongest At-Home Light Therapy Laser Claims to Stop Aging In Its Tracks—& It's on Sale I Found the Best Baggu ...
FDA Approves Feasibility Study with SeaStar Medical’s Selective Cytopheretic Device in Adults with Cardiorenal Syndrome
Study to be conducted under $3.6 million NIH grant DENVER, Jan. 13, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), ...
rheumatologyadvisor2d
FDA Drug Approval Decisions Expected in February 2025
The FDA is reviewing new vaccines for meningitis and chikungunya and therapies for Parkinson disease and PTSD.
JD Supra3d
FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
JD Supra4d
Streamlining Device Changes with Predetermined Change Control Plans (PCCPs)
In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a ...
ABC72d
FDA approves Zyn nicotine pouches, citing health benefits for adult smokers
The newest nicotine product comes in multiple different flavors and is growing in popularity among teenagers. Zen is *** tiny ...
SeaStar Medical says FDA approves feasibility study with SCD-ADULT
SeaStar Medical (ICU) announced that the U.S. FDA has approved an investigational device exemption application to evaluate the safety and ...