FDA approves a Pfizer BLA for Nivestym (filgrastim-aafi), a biosimilar product referencing Amgens Neupogen, indicated for treating neutropenia.
FDA grants Sellas Life Sciences Group a fast track designation for its galinpepimut-S and its use in treating multiple myeloma.
FDA commissioner Scott Gottlieb and two colleagues write about new efforts to understand changes in substance abuse and respond effectively.
FDA commissioner Scott Gottlieb says the agency is looking into ways it could safely approve short-term importation of some drugs that are in short su...
CDER director Janet Woodcock announces a reorganization affecting nearly one-third of the Centers offices.
Federal Register notice: FDA makes available a final guidance entitled Labeling for Biosimilar Products.
Federal Register notice: FDA makes available a draft guidance entitled Use of Electronic Health Record (EHR) Data in Clinical Investigations.
FDA releases an FDA-483 issued following an inspection at Indias Hetero Drugs.