FDA approves Incytes Monjuvi (tafasitamab-cxix) in combination with lenalidomide and rituximab for treating adults with relapsed or refractory follicu...
FDA clears a DeepEcho 510(k) for its artificial intelligence-based fetal ultrasound analysis platform.
FDA approves a Cycle Pharmaceuticals NDA for Harliku (nitisinone) tablets for reducing urine homogentisic acid in adult patients with alkaptonuria.
FDA warns that Baxter Healthcares antinausea patch Transderm Scop (scopolamine transdermal system) can increase body temperature and cause heat-relate...
Bloomberg News says President Trump and HHS secretary Kennedy are looking at policies that they hope would drive drug companies away from DTC advertis...
FDA approves Gileads Yeztugo as the only HIV pre-exposure prophylaxis twice-yearly option.
FDA publishes a guidance on its implementation of the post-Warning Letter meeting established in the GDUFA 3 commitment letter to allow eligible facil...
House Energy and Commerce Committee ranking Democrat Frank Pallone calls for a bipartisan committee investigation of HHS secretary Robert Kennedys act...