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.
FDA asks a Texas federal court to reject an Association for Hippocratic Medicine request for a preliminary injunction to overturn the agencys approval...
Moderna says it will seek regulatory approval for an investigational mRNA RSV vaccine for use in older adults.
SFJ Pharmaceuticals says it has closed the sale and transfer of assets related to bentracimab from PhaseBio Pharmaceuticals, and it is planning to fil...