The boundary between science fiction and medical reality blurs as companies like Elon Musk's Neuralink make strides in ...

The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...

Michelle Tarver, MD, PhD, a 15-year veteran of the agency, is stepping into a pivotal role as the new director of the FDA's device division, taking over for Jeffrey Shuren, MD. Dr. Shuren's tenure was ...

Shortly after 2 a.m. on a Saturday in a midtown Manhattan sports bar packed with Aussies, Dr. Tom Oxley was feeling stunned.

Novavax said the Food and Drug Administration allowed it to continue testing a combination COVID-19-flu and standalone flu vaccine that had been put on hold.

The U.S. Food & Drug Administration has approved Johnson & Johnson's device for a type of condition which causes abnormal ...

Kamen and Sequel Medtech CEO Alan Lotvin say they are offering greater precision in insulin delivery with new pump technology ...

FDA approves Autolus Therapeutics' Aucatzyl for adults with relapsed or refractory B-cell precursor acute lymphoblastic ...

Autolus Therapeutics said it received Food and Drug Administration approval of its treatment of acute lymphoblastic leukemia, or ALL, an aggressive blood and bone marrow cancer, for certain patients.

Elon Musk contributed at least $119 million to a pro-Trump spending group and tirelessly touted the former president at the ...

J&J is the third medtech company to gain U.S. approval for pulsed field ablation, a new atrial fibrillation treatment seeing rapid adoption.

Mirikizumab is a drug currently approved by the Food and Drug Administration (FDA) for the treatment of ulcerative colitis. Pharmaceutical company Eli Lilly recently released findings of two ...