The 7th Circuit Court of Appeals affirms a lower court decision dismissing a suit charging that AbbVies filing of 132 additional Humira patents violat...
Federal Register notice: FDA seeks comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling change...
Speaking at an Alliance for a Stronger FDA Webcast, FDA principal deputy commissioner Janet Woodcock says FDA is working toward new efficiencies throu...
Former CDER combination product team leader Jay Jariwala joins the Sidley law firm.
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...