FDA

Nephrodite’s device designed to ‘free patients from the cycle of center-based dialysis’ becomes the first to receive the designation. Medical device startup Nephrodite has received Breakthrough Device Designation from the …

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech …

DOVER, N.H. — Not long after he woke from surgery in June, Bill Stewart made a  pact with his newest organ. He wasn’t sure how long the thing would last. …

Scientists have reached a major milestone in animal-to-human transplant research as the U.S. Food and Drug Administration has approved the first human clinical trials for kidney transplants from genetically modified …

Massachusetts-headquartered biotech eGenesis announced on Monday that the US FDA has cleared its clinical trial application to evaluate gene-edited pig kidneys in patients with end-stage kidney disease (ESKD). The company, …

Propublica is a nonprofit newsroom that investigates power abuse. Sign up and receive the biggest story as soon as it's published. Joe DeMayo always knew that his healthy years could …

Tuesday, February 4, 2025 (Healthday News) – The US Food and Drug Administration (FDA) took a major step in interspecies transplantation by testing pig kidney transplants in its first clinical …

The 66-year-old human organ transplant agent Andrews' Good Morning America Abbey Knap Through is the first recipient of genetically modified pig kidneys in a multi-patient study of FDA. …2 days …

Once-Daily Oral HIF-PH Inhibitor Activates Physiologic Response to Manage Anemia  Akebia’s Launch Strategy Developed to Drive Toward a Potential New Oral Standard of Care Company to Host Conference Call on …