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

Agriculture Secretary Brooke Rollins and Health and Human Services Secretary Robert F. Kennedy Jr. will hold a news briefing ...

British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to extend the ...

The FDA has approved the natural color additive gardenia (genipin) blue for use in various foods and drinks at “levels ...

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

The White House asked companies to remove Red No. 3, an artificial color in candy and cereal, sooner than the 2027 deadline ...

Gardenia (genipin) blue is the fourth natural food color additive to be approved by the FDA this year. This is how it's made.

While the complete response letter derails a near-term clearance, one analyst described the rejection as more of “a speed ...

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

FDA Commissioner Marty Makary's vision for the agency risks the best of an agency that mostly has functioned well for the ...

Capricor Therapeutics's dip caused by the CRL is a buying opportunity considering the readout of HOPE-3 within 2-3 months.

Kerendia was originally approved in July 2021 to reduce cardiovascular and kidney complications in patients with chronic ...