FDA approves a SK Life Science NDA for Xcopri (cenobamate tablets) for treating partial-onset seizures in adults.
FDA posts a summary of the deliberations during an 11/13-14 Immunology Devices Panel of the Medical Devices Advisory Committee meeting, which recommen...
HHS publishes the latest unified rule agenda including 85 FDA items.
Federal Register notice: FDA makes available a draft guidance entitled Transdermal and Topical Delivery Systems Product Development and Quality Consi...
Federal Register notice: FDA sends to OMB a proposed information collection on Web-Based Pilot Survey To Assess Allergy to Cosmetics in the United Sta...
Federal Register notice: FDA sends to OMB an information collection extension for its Guidance for Industry on Dear Health Care Provider Letters: Impr...
FDA releases FDA-483s from inspections at two Aurobindo units in India.
FDA works with Australia and Canada to approve a new indication for AstraZenecas Calquence.