FDA sends Eli Lilly a complete response letter for its accelerated approval BLA submission for donanemab, indicated for treating early symptomatic Alz...
Federal Register notice: FDA seeks comments on an information collection extension entitled Adverse Event Program for Medical Devices (Medical Product...
Federal Register notice: FDA sends to OMB an information collection extension entitled Protection of Human Subjects; Informed Consent; and Institution...
Rep. Frank Pallone asks FDA and NIH what they are doing to enforce compliance with ClinicalTrials.gov reporting requirements.
FDA denies Fresenius Kabis request that its glycopyrrolate solution receive a therapeutic equivalent rating with Hikmas Robinul.
Attorneys James Bolani and Bonnie Odom discuss a Consolidated Appropriations Act provision that clarifies the regulatory status of contrast agents, ra...
FDA solicits stakeholder views on external organizations that could receive real-world data funding from MDUFA 5.
Janssen says it will discontinue its Mosaico Phase 3 trial of an HIV vaccine after a data review showed the vaccine was not effective.
