FDA denies a Synergy Pharmaceuticals petition asking that it order Forest Laboratories to make changes to the Linzess prescribing information.
Former FDA commissioner Stephen Hahn joins clinical therapeutics startup Blackfynns board of directors.
Federal Register notice: FDA seeks comments on an information collection extension for Shortages Data Collections.
FDA releases its latest batch of Warning Letters that include CooperSurgical and Dr. Paul's Lab.
GSK Healthcare asks FDA to change its approach in a draft guidance on labeling OTC drugs.
FDA says Pacific Stem Cells is marketing unapproved stem cell products to treat several diseases and conditions.
A new study finds that racial/ethnic minority groups and older adults are underrepresented in U.S.-based vaccine clinical trials.
Federal Register notice: FDA seeks comments on an information collection extension entitled Current Good Manufacturing Practices and Related Regulatio...