The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational gene therapy trials for limb girdle muscular dystrophy following three patient deaths potentially linked to the company's treatments.

The Food and Drug Administration on Monday named George Tidmarsh, a longtime biotech executive who has a background in oncology and pediatrics, as its top drug regulator. Tidmarsh

Sarepta Therapeutics traded lower on Monday, extending a slide as the company took the unusual step of refusing a Food and Drug Administration request to stop selling a drug tied to three deaths.

The US Food and Drug Administration aims to revoke 52 standards of identity (SOI) across a swath of food categories, claiming the regulations are “obsolete and unnecessary.” Under the proposal, announced July 16,

Scientists at UCSF and Gladstone Institutes have identified cancer drugs that promise to reverse the changes that occur in the brain during Alzheimer’s, potentially slowing or even reversing its symptoms.

American depositary receipts of RedHill Biopharma climbed after the company said it received positive Food and Drug Administration feedback on its treatment for Crohn's disease. The ADRs were up 24%, to $2.30, midday Monday. They have slipped about 63% so far this year.

US Food and Drug Administration Commissioner Marty Makary signaled Thursday that he is open to revising strict warning labels on Hormone Replacement Therapy.

Attention to synthetic food dyes is only one small element of a much larger and complicated public health enterprise, and its ultimate impact can only be assessed as part of this whole.