FDA updates Covid test FAQs with an explanation of current agency priorities for reviewing test EUA requests.
FDA says MPM Medical has recalled one lot of Regenecare HA Hydrogel due to bacterial contamination.
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.