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 ...

NT-501 is an investigational ocular implant that utilizes an encapsulated cell-based delivery system to deliver continuous ciliary neurotrophic factor.

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

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

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.

The FDA has approved a new oral antibiotic to treat uncomplicated urinary tract infections. Orylnvah is a broad-spectrum oral penem antibiotic for women who have limited or no alternative ...

Johnson & Johnson MedTech will enter the U.S. pulsed field ablation market following an FDA green light for its Varipulse ...

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.

Tom Oxley, the Australian-born chief executive of brain chip company Synchron, has praised ­Donald Trump for having a ...