Former FDA commissioner Andrew C. von Eschenbach and former HHS secretary Tommy G. Thompson urge policymakers to prioritize leadership and institution...
A new policy report urges sweeping FDA reforms, arguing that shortening the time required to bring drugs, biologics and medical devices to market coul...
FDA appoints Lisa Romano as principal deputy associate commissioner for inspections and investigations, elevating a 24-year agency veteran to one of t...
Fulcrum Therapeutics says it is discontinuing development of its lead sickle cell disease candidate, pociredir, after receiving feedback from FDA.The ...
FDA and the drug industry conclude technical negotiations over the next iteration of the Prescription Drug User Fee Act, setting the stage for broader...
An FDA crackdown on allegedly deceptive prescription drug advertising leads to a sharp increase in pharmaceutical advertising spending on television a...
FDA posts a draft guidance that proposes streamlined nonclinical safety testing approaches for certain oncology biologics and conjugated therapies.
ICH updates its long-running question-and-answer guidance tied to the ICH Q8, Q9 and Q10 pharmaceutical quality guidelines.
