CDRH seeks proposals for medical device site visits as part of its Experiential Learning Program, which is intended to educate the Center on how new t...
Regenxbio plans a BLA using the accelerated approval pathway for its RGX-121 Hunter Syndrome treatment.
FDA issues a Form FDA-483 to Aurobindo Pharma, citing three observations after investigators inspected the firms Unit XI, an active pharmaceutical ing...
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...
