The U.S. Food and Drug Administration has declined to approve Ultragenyx Pharmaceutical's experimental gene therapy to treat ...

Class II recalls from the FDA indicate a potential risk to consumer safety where use or exposure to the product may cause ...

Presented by Express Scripts Pharmacy Benefit Services{beacon} Health Care Health Care   The Big Story Senate panel clears ...

It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...

A long-acting flea and tick treatment from Merck Animal Health has earned approval for dogs at least six months old from the Food and Drug Administration (FDA).

Moderna's COVID-19 vaccine has received full approval from the U.S. Food and Drug Administration (FDA) for use in children ...

The FDA is urging customers with a milk allergy to avoid consuming the recalled chocolate products. Customers can also return the products to where they were purchased for a full refund, according to ...

The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...

A coalition of ALS patients and caregivers is petitioning the FDA to review available data on the stem cell therapy NurOwn ...

Capricor Therapeutics said on Friday the U.S. Food and Drug Administration has declined to approve its cell therapy deramiocel for a heart condition associated with Duchenne muscular dystrophy.

WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...