FDA accepts for priority review a Janssen BLA for an investigational treatment for relapsed/refractory multiple myeloma.
FDA publishes two draft guidances on the continued surveillance of certain FDA-approved and cleared medical devices.
Federal Register notice: FDA announces the availability of FDA guidance documents related to the Covid-19 pandemic.
Federal Register notice: FDA updates its administrative records to reflect two Emergency Use Authorizations for biological products for use during the...
FDA says it is restricting the use of Intercepts Ocaliva in patients with primary biliary cholangitis and advanced cirrhosis of the liver.
In a sharply worded notice, FDA acting commissioner Janet Woodcock says the agency is reversing a Trump administration HHS notice intended to end the ...
FDA puts a clinical hold on the Larimar Therapeutics clinical development program for CTI-1601 to treat Friedreichs ataxia.
FDA updates its guidance on Covid-19 EUAs to reflect that it may decline to review and process further EUA requests other than those for vaccines whos...