Eight House Democrats ask FDA acting commissioner Kyle Diamantas what the agency is doing and can do to ease a growing shortage of estrogen patches us...
Two senior U.S. senators seek answers from FDA about its plans to address ongoing shortages of several critical chemotherapy drugs.
FDA outlines its intention to overhaul the early-stage clinical development process through a planned Expedited IND Pilot, arguing that the changes ar...
FDA issues a finalized guidance on evaluating the safety of antimicrobial animal drugs based on their role in human medicine.
FDA seeks information from a variety of regulatory partners that will help it establish and implement a Quantitative Medicine Innovation Network.
FDA and Tonix Pharmaceuticals align on the protocol for an adaptive Phase 2 study of the companys TNX-4800 to prevent Lyme disease.
An FDA inspection cites multiple manufacturing and quality system deficiencies at a Zydus Lifesciences Limited sterile manufacturing facility in Ahmed...
FDA approves Takedas Orzeyful as the first drug to treat all symptoms of narcolepsy type 1 in adults.
