FDA plans to ask an advisory committee 7/25 whether a new trial should be conducted before approving an AstraZeneca supplemental BLA for Imfinzi (durv...
Federal Register notice: FDA corrects a 7/2 notice that announced the determination of the regulatory review period for Sanofis Xenpozyme (olipudase a...
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.
