FDA issues Lipocine a complete response letter on its NDA for Tlando, an oral testosterone product candidate for testosterone replacement therapy in a...
Federal Register notice: FDA submits to OMB an information collection extension for Format and Content Requirements for Over-the-Counter Drug Product ...
Start-up pharmacy Valisure makes a name for itself by chemically validating drugs it purchases from wholesalers before fulfilling prescriptions for co...
Regenxbio files a lawsuit in DC federal court against FDA, challenging a clinical hold on its gene therapy for retinal diseases.
FDA grants AI Medical Service a Breakthrough Device Designation for its artificial intelligence programs that analyze endoscopy images for diagnosing ...
FDA grants Allergan a Qualified Infectious Disease Product designation and fast track status for ATM-AVI (aztreonam and avibactam) for treating certai...
FDA Review posts the Federal Register notices for the week ending 11/8/2019.