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

The U.S. Food and Drug Administration on Monday approved the use of a new blue color additive from the gardenia fruit the ...

The U.S. Food and Drug Administration approved a new blue color additive derived from the fruit of the gardenia, a flowering ...

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 ...

Del-zota is designed for patients with mutations amenable to exon 44 skipping, which is just 7% of the overall DMD patient ...

Bravecto Quantum is the first FDA-approved drug that treats and prevents flea and tick infestations on dogs for a duration of ...

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

An FDA advisory panel will meet July 18 to consider a supplemental new drug application for the antipsychotic brexpiprazole, ...

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

Finerenone gained FDA approval for heart failure treatment, showcasing significant benefits in reducing cardiovascular events ...

The FDA evaluates glofitamab and daratumumab for lymphoma and myeloma treatments, highlighting trial demographics and ...

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