FDA expands its drug quality enforcement efforts since the end of the Covid-19 Public Health Emergency, with foreign oversight reaching all-time highs...
FDA lifts an earlier recommended pause on the use of Valnevas Ixchiq vaccine for chikungunya virus.
FDA says it is starting the FDA PreCheck program to help drug companies develop manufacturing facilities in the U.S.
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...
