The FDA’s decision to ban dyes and other synthetic substances often rests on the Delaney clause, a 49‑word law from 1958 that ...

Q32 Bio shares drew renewed attention on Wednesday after the FDA granted Fast Track designation to its experimental alopecia areata treatment, bempikibart. The designation could accelerate development ...

Prior to starting the trial, the participants also had moderate to high levels of scar tissue in the liver, known as stage 2 ...

May has just begun, and it's time to turn our attention to the FDA decisions on deck for the coming weeks.So far this year, the U.S. regulatory agency has approved only ...