Federal Register notice: FDA sets the rates for prescription drug user fees for fiscal year 2023.
FDA approves a Roche PMA for the Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify metastatic breast cancer patients with low...
Federal Register notice: FDA announces a 12/14 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss a Viatris Specialty supplemental N...
Federal Register notice: FDA announces a 12/13 Cardiovascular and Renal Drugs Advisory Committee meeting to review a Cytokinetics NDA for omecamtiv me...
FDA publishes a guidance with updated GDUFA 3 information on information requests and discipline review letters.
FDA publishes a guidance with information on competitive generic therapies.
GlaxoSmithKline announces positive results from the Phase 2 PERLA trial of its lung cancer drug Jemperli.
FDA will not hold a pre-EUA meeting with Eigen BioPharmaceuticals on its possible use of peginterferon lambda to treat Covid-19.
