Johnson & Johnson seeks approval of Spravatos (esketamine) approval as monotherapy for adults living with treatment-resistant depression.
FDA approves a Samsung Bioepis BLA for Epysqli (eculizumab-aagh) as a biosimilar to Alexions Soliris (eculizumab), indicated for treating patients wit...
New studies by FDA drug promotion staff find that consumers conflated a drugs benefits and risks when they were exposed to both a disease awareness co...
Ionis Pharmaceuticals reports favorable data from a Phase 1/2 open-label study of ION582 in people with Angelman syndrome.
FDA clears a Varian 510(k) for new functionality to its Ethos radiotherapy system for treating cancer.
FDA grants Tulavi Therapeutics a de novo marketing authorization for its Allay Nerve Cap, a surgical hydrogel designed to protect transected nerves to...
FDA posts a draft guidance entitled Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products; Questions and Answers. ...
