Raniers Rx Laboratory recalls all sterile compounded drug products within expiry to the hospital or consumer level due to concerns that practices at t...
Federal Register notice: FDA publishes a list of information collections that have been approved by OMB under the Paperwork Reduction Act.
Federal Register notice: FDA extends until 11/2 the effective date of its order withdrawing approval of ANDAs for the prescription polyethylene glycol...
FDA approves Progenics Pharmaceuticals Azedra for treating some rare adrenal tumors that require systemic anticancer therapy.
FDA clears a Sekisui Diagnostics 510(k) for the Sekure HbA1c assay and its use as an aid in diagnosing diabetes mellitus.
FDA issues a draft guidance with recommendations to reduce the risk of transfusion-transmitted babesiosis.
Rep. Jan Schakowsky (D-IL) introduces four bills intended to lower drug prices.
FDA accepts for review a Nektar Therapeutics NDA for NKTR-181 for treating chronic low back pain in adult patients new to opioid therapy.