The FDA Friday issued a draft guidance to clarify what establishments and types of food are covered by the menu labeling rule, how to determine calorie counts, and how and where calorie counts should ...

With 99% of patients experiencing an adverse event, the FDA is skeptical that the risks associated with Geron’s myelodysplastic syndromes (MDS) medicine imetelstat outweigh the potential benefit of ...

On Oct. 23, the FDA issued draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses [SIUU] of Approved/Cleared Medical Products: ...

With states like California, Illinois, and New York questioning the safety of certain food additives and some other chemicals used in food, the public is wondering if a food is safe to eat if it ...

The FDA is raising efficacy questions over Lundbeck and Otsuka’s proposed combination of their Rexulti with Viatris’ Zoloft as a treatment for post-traumatic stress disorder (PTSD). For an upcoming ...

Martin Makary nominated to serve as Commissioner of Food and Drugs at the Department of Health and Human Services, testifies before the Senate Committee on Health, Education, Labor and Pensions on ...

President Donald Trump’s pick to lead the Food and Drug Administration largely sidestepped questions Thursday from senators about how he would handle numerous pressing issues before the agency, ...