House Energy and Commerce Committee leadership denounces the White House after it blocked FDA commissioner Stephen Hahn from testifying before the Com...
Medimetriks Pharmaceuticals says it received a Type C Meeting written response from FDA on MM36 (difamilast) for the topical treatment of mild to mode...
FDA grants Junshi Biosciences an orphan drug designation for toripalimab and its use in treating soft tissue sarcoma.
The CDER Office of Prescription Drug Promotion says it wants to ask medical conference healthcare professional attendees about their experiences at dr...
FDA publishes a table comparing the performance of over 50 Covid-19 molecular diagnostic tests.
FDA clears a Acutus Medical 510(k) for the second-generation AcQMap 3D imaging and mapping catheter.
Former FDA associate commissioner Peter Lurie says historic data on vaccine trials should lead to a realistic understanding that some or even all curr...
Federal Register notice: FDA proposes to reclassify Class 3 cytomegalovirus deoxyribonucleic acid quantitative assay devices intended for transplant p...