Celgene submits an NDA for ozanimod for treating adults with relapsing forms of multiple sclerosis.
FDA commissioner Scott Gottlieb discusses steps the agency is taking to help medical device patients cope with potential shortages due to closure of s...
FDA releases its latest batch of Warning Letters that include Mariposa Labs and Thibiant International.
FDA warns Thibiant International about CGMP violations in its production of finished pharmaceuticals.
Janssen Pharmaceutical files a supplemental BLA seeking approval of Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethaso...
Federal Register notice: FDA seeks comments on an information collection extension for Clinical Laboratory Improvement Amendments (CLIA) of 1988 waive...
Federal Register notice: FDA makes available a final guidance entitled Standards Development and the Use of Standards in Regulatory Submissions Review...
CDER regulatory advisor Joshua Silverstein uses a Webinar to describe provisions in the final guidance on the least burdensome approach to regulatory ...