Former CBER investigator and reviewer John Godshalk joins NDA Partners as an expert consultant.
FDA clears a Viveve Medical 510(k) to expand its manufacturing capacity for its consumable treatment tips used with the companys Cryogen-cooled Monopo...
Janssen Pharmaceutical files a BLA for amivantamab for treating certain patients with metastatic non-small cell lung cancer.
FDA alerts health care professionals about the risk of inadvertent intrathecal administration with tranexamic acid injection, which may result in seri...
TG Therapeutics begins a rolling BLA submission for ublituximab in combination with umbralisib as a treatment for patients with chronic lymphocytic le...
FDA publishes the latest update to the SARS-CoV-2 reference panel of standardized samples.
FDA approves a Vanda Pharmaceuticals NDA for Hetlioz (tasimelteon) capsule and liquid formulations for treating adults and children with nighttime sle...
Federal Register notice: FDA announces a 12/17 advisory committee meeting to discuss an emergency use authorization request by Moderna for its Covid-1...