FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), Mercks anti-PD-1 therapy as monotherapy for treating patients w...
FDAs Office of New Drugs denies a Lexicon Pharmaceuticals appeal of a March Complete Response Letter on its NDA for diabetes drug Zynquista (sotaglifl...
FDA Review posts the Federal Register notices for the week ending 11/29/2019.
Federal Register notice: FDA debars Tzvi Lexier for 10 years from importing any drug into the U.S. because he was convicted for conspiracy to smuggle ...
FDA withdraws approval of six ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed.
Federal Register notice: FDA makes available a draft guidance entitled Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insul...
FDA approves a Qiagen and DiaSorin PMA for the automated workflow for QuantiFeron-TB Plus, a fourth-generation test for latent tuberculosis detection.