Merck and Eisai say the combination of Keytruda and Lenvima failed to meet two primary endpoints in a test of patients with unresectable hepatocellula...
Some 99 health-related advocacy and service groups call on Congress to resume consensus talks on user fee reauthorization legislation.
Pfizer discontinues developing PF-07265803 in patients with symptomatic dilated cardiomyopathy after an interim futility analysis of the global Phase ...
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that address bioequivalence study design re...
Charles River Laboratories petitions FDA to exercise regulatory oversight over both natural and synthetic endotoxin contamination assays.
Attorney and data scientist Bradley Thompson says FDA data support the value of a breakthrough device designation for de novo submissions but not for ...
CDRH director Jeffrey Shuren describes Center efforts to help sterilization facilities to reduce ethylene oxide emissions into the environment.
FDA approves Allergan Aesthetics Juvderm Volux XC for improving jawline definition in adults over the age of 21 with moderate to severe loss of jawlin...