The FDA expanded the indication for finerenone (Kerendia) in heart failure (HF), drug manufacturer Bayer announced.

The Gardenia Blue Interest Group, which petitioned the government to approve the dye, has asked the FDA to make an exemption for the dye from being labeled as an allergen due to the soy protein. Soy ...

The U.S. Food and Drug Administration approved a new blue color additive derived from the fruit of the gardenia, a flowering evergreen, for use in a variety of drinks and candies.

The FDA is expected to decide on treatments for bronchiectasis, chronic immune thrombocytopenia, fibromyalgia, Friedreich ataxia, and recurrent respiratory papillomatosis.

The U.S. Food and Drug Administration announced it had granted Gardenia Blue Interest Group’s (GBIG) color additive petition ...

The US Food and Drug Administration has approved the use of finerenone (Kerendia) in heart failure (HF) patients with mildly ...

The U.S. Food and Drug Administration (FDA) announced its approval of a fourth natural food color Monday, the latest action in the Trump administration’s Make America Healthy Again (MAHA) initiative ...

The U.S. Food and Drug Administration has approved Bravecto Quantum, a new shot that protects dogs six months or older ...

The FDA approved a natural blue food dye amid a push to phase out synthetic additives. Here's what to know about gardenia (genipin) blue.

Many FDA accelerated approvals continue to rely heavily on surrogate endpoints, raising ongoing uncertainty about the true clinical benefits of these therapies.

On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in ...

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