FDA approves a Johnson & Johnson supplemental BLA for Tecvayli (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks in patie...
United Therapeutics sues FDA over its decision to permit Liquidia to seek a second indication for its Yutrepia by amending its pending NDA rather than...
Federal Register notice: FDA amends its standing advisory committee regulations to add the new Digital Health Advisory Committee.
FDA cautions device manufacturers to evaluate the performance data provided by third-party labs for use in agency submissions.
CBER publishes a SOPP for the administrative handling, review, and reporting of postmarketing requirements and commitment submissions.
Two Coalition for a Prosperous America policy experts outline steps they say the federal government, including FDA and Congress, can take to address c...
An FDA-funded survey of doctors who prescribe REMS-covered drugs finds that many doctors appreciate and use the REMS information and want more informa...
FDA clears an X-trodes 510(k) for its X-trodes Smart Skin device, a wireless wearable technology for advanced electrophysiological monitoring.
