The International Council for Harmonization posts a presentation outlining its finalized guidance entitled A Selective Approach to Safety Data Collect...
Federal Register notice: FDA makes available a draft guidance entitled In Vitro Permeation Test Studies for Topical Products Submitted in ANDAs.
Federal Register notice: FDA makes available a draft guidance entitled Physicochemical and Structural (Q3) Characterization of Topical Drug Products i...
Janssen Pharmaceutical says new data show that patients given Tremfya (guselkumab) saw a clinical response rate of about 80% in trial subjects with mo...
Responding to a petition seeking the removal of approval for Jazz Pharmaceuticals lung cancer drug Zepzelca, FDA explains why it doesnt agree with the...
FDA gives accelerated approval to Janssens teclistamab-cqyv for some adults with relapsed or refractory multiple myeloma.
FDA medical reviewers tell members of the Cardiovascular and Renal Drugs Advisory Committee there are safety concerns with GlaxoSmithKlines anemia dru...
Federal Register notice: FDA makes available a draft guidance entitled In Vitro Release Test Studies for Topical Products Submitted in ANDAs.
