The U.S. FDA finalized a guidance for third-party servicing of medical devices, which helps to clarify the distinction ...

In a research collaboration that could bring in up to $600 million, Metaphore Biotechnologies Inc. has become the third ...

Field Medical Inc. kicked off its first-in-human study for its Fieldforce ablation system, designed for use in ventricular ...

Newco Commit Biologics ApS has arrived on the scene after raising €16 million (US$17.2 million) in a seed round to advance ...

Right on cue, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) is scheduling its first in-person advisory ...

Prenatal therapies are the next disruptive technologies in health care, which will advance and shape the future of patient ...

Nanite Inc. has been awarded a $1.8 million grant by the Bill & Melinda Gates Foundation to design and optimize polymeric ...

Researchers have developed a method to repair nerve connections in patients with spinal cord injuries using red and near-infrared light. The team from the University of Birmingham, U.K., are now ...

Tiumbio Co. Ltd., of Seongnam-si, Gyeonggi-do, reported positive phase IIa top-line data on May 8 for Merigolix, its lead asset to reduce pain in female patients with moderate to severe endometriosis.

In a May 8 Senate hearing, U.S. FDA commissioner Bob Califf described the agency’s advisory committee process as a useful source of information, but Califf reassured members of the Senate that the FDA ...

Three years ago when Keting Chu pondered the name for a new biopharma company that would fold in infectious disease assets from Novartis AG, she looked out over her West Coast backyard. “I was looking ...

Researchers at Biogen Inc. and Broad Institute Inc. have divulged glycogen synthase kinase-3α (GSK3A; GSK-3α) inhibitors reported to be useful for the treatment of cancer, neurological and metabolic ...