FDA and FibroGen reach an agreement on key elements in a Phase 3 trial of the companys roxadustat to treat some chemotherapy-induced anemias.
FDA publishes a draft International Council on Harmonization guideline for extractables and leachables to solicit public comment.
Former FDAer Julie Tierney is now a principal in Leavitt Partners Washington office.
FDA issues Johnson & Johnson a complete response letter for its supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) in a quadrup...
FDA approves an Instylla PMA for its Embrace Hydrogel Embolic System, a liquid embolic device for treating hypervascular tumors in peripheral arteries...
FDA says it will allow up to 12 months for doctors to transition patients who are taking unapproved animal-derived thyroid medications to approved syn...
Eli Lilly says it will file an NDA by the end of the year for its investigational obesity treatment orforglipron, based on just-announced Phase 3 data...
FDA issues an early alert based on a Boston Scientific letter to customers about certain Endotak Reliance defibrillation leads that may impact shock e...