Grifols, a global leader in plasma medicines, has received approval from the U.S. Food and Drug Administration for its new immunoglobulin (Ig) purification and filling facility at its Clayton manufacturing campus, one of the world’s largest sites for producing plasma-derived medicines.
Read More
Peripheral artery disease affects around 1 in 20 Americans over the age of 50, occurring when blood flow is limited by blocked arteries. The patients were treated with the implantation of a Human Acellular Vessel (HAV), a bioengineered tissue, to from Humacyte to facilitate revascularization.
Read More
The FDA expects the Triangle Center of Excellence in Regulatory Science and Innovation (CERSI) to provide “essential new information, as well as infrastructure and tools to shorten the drug and device development process, to advance public health and to inform regulatory decision making and guidance documents.”
Read More
The U.S. approved the first vaccine for RSV on Wednesday, shots to protect older adults against a respiratory virus that’s most notorious for attacking babies but endangers their grandparents, too.
Read More
The Food and Drug Administration will now require medical devices meet specific cybersecurity guidelines after years of concerns that a growing number of internet-connected products used by hospitals and healthcare providers could be hit by hacks and ransomware attacks.
Read More
The FDA has filed complaints against four makers of e-cigarette products, noting they did not receive authorization to sell in the US.
Read More
U.S. health officials on Friday approved a closely watched Alzheimer’s drug that modestly slows the brain-robbing disease, albeit with potential safety risks that patients and their doctors will have to carefully weigh.
Read More
Baebies, a medical device and diagnostics company in Durham, has received permission from the U.S. Food and Drug Administration to market a rapid, point-of-care test for the world’s most common enzyme deficiency.
Read More
U.S. officials have approved the first pharmaceutical-grade version of the so-called fecal transplant procedures that doctors have increasingly used against hard-to-treat intestinal infections.
Read More
