FDA commissioner Robert Califf and other top officials outline areas the agency believes can be optimized to help improve the advice received from adv...
FDA approves Establishment Labs Holdings Motiva SmoothSilk Ergonomix and Motiva SmoothSilk Round breast implants for breast augmentation.
CDRH posts four dental final guidances under its Performance Criteria for Safety and Performance Based Pathway program.
FDA approves Sanofi and Regenerons Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive...
FDA approves Bristol-Myers Squibbs Cobenfy (xanomeline and trospium chloride) capsules for treating schizophrenia in adults.
Federal Register notice: FDA seeks consumer organizations interested in participating in the selection process for voting or nonvoting consumer repres...
Federal Register notice: FDA announces that four information collections have been approved by OMB.
The U.S. 9th Circuit Court of Appeals reverses an earlier California lower court decision that ruled a stem cell treatment firm is exempt from FDA reg...
