A primary benefit of the FDA Fast Track designation is how it accelerates the drug approval process. Early and continuous ...

Connecting decision makers to a dynamic network of information, people and ideas, Bloomberg quickly and accurately delivers ...

US-based device company Nevro has secured market authorisation from the European Union (EU) for its HFX iQ spinal cord ...

Four years after winning an FDA approval for Koselugo to treat children with the rare disorder neurofibromatosis type 1 (NF1) ...

Imagine moving a computer mouse with only your thoughts. You think it, and it's done. It may be science fiction, but it's ...

Discover how Remedy Logic's FDA-cleared RAI program, powered by AI, is revolutionizing spine MRI interpretation for radiologists and patients.

Nevro's HFX iQ spinal cord stimulator earned the European Union's CE mark, the company said Nov. 12.

Compounding pharmacies are typically allowed to make copies of drugs that are deemed to be in shortage by the FDA, which semaglutide has been for over two years. But Novo argued that semaglutide ...

Science Corporation, a biotech startup launched by a Neuralink cofounder, claims that it's achieved a breakthrough in brain-computer interface technology that can help patients with severe vision ...

This is the first approved indication for Orlynvah and the first FDA-approved product for Iterum. The FDA approval was based on a clinical development program, including two Phase 3 clinical trials.

Baxter has received FDA approval to extend the shelf life of more than 50 intravenous and irrigation products by up to 12 months, now allowing for a 24-month expiry from products made before ...

Oct. 28, 2024 –The FDA has approved Orlynvah, a new oral treatment for uncomplicated urinary tract infections (UTIs) in women who have limited options for effective antibiotic therapy.