Gerry Smith

The US Food and Drug Administration has no plans to put a “black box” warning on Covid vaccines, the agency’s top official said, despite a recent report that US regulators were preparing to add a new caution to the immunizations.

Sarepta Therapeutics Inc.’s controversial gene therapy for a rare muscle condition will remain available in the US with a strict new warning about potentially deadly liver injuries, a regulatory decision that removes the risk it would be pulled from the market.

US regulators laid out new guidelines for approving custom-made treatments for individual patients, a move that could bring the promise of gene editing to more people with devastating diseases.

A top US regulator plans to unveil a faster approach to approving custom gene-editing treatments, a move designed to unleash a wave of industry investment that will yield cures for patients with rare diseases.

Bristol Myers Squibb Co. raised its revenue outlook for the year after newer medicines outperformed expectations, easing pressure on its portfolio of aging blockbusters.

Biogen Inc. cut its full-year profit guidance on higher costs from deals the company has been doing to offset the decline of its aging multiple sclerosis drugs.

Hi, it's Gerry in New York, where schools have banned smartphones in the classroom for the first time. I spoke to one high school student in a neighboring state about how a phone ban at his school has affected his mental health. But first ...

BridgeBio Pharma Inc.’s drug to treat a devastating muscle-wasting disorder met its goal in a late-stage trial, paving the way for the biotech company to seek US approval.

Intellia Therapeutics Inc. paused clinical trials for its gene editing treatments after a patient was hospitalized with liver damage, a setback as it seeks to sell the first one-time treatment for heart and nerve conditions.

Moderna Inc. said its vaccine to prevent cytomegalovirus, a common cause of birth defects, failed to meet its goal in a late-stage trial, a setback for the company still struggling to move past the pandemic.