FDA removes a partial clinical hold against Foghorn Therapeutics Phase 1 monotherapy dose escalation study of FHD-286 in acute myelogenous leukemia an...
Draeger Medical recalls its ventilator set, tubing and support (with harness) because glued connections on the breathing circuit can become loose.
FDA places an import alert on drug products manufactured by Intas Pharmaceuticals in Ahmedabad, Gujarat, India due to significant GMP violations docum...
FDA extends by three months its review of a SpringWorks Therapeutics NDA for nirogacestat for treating adults with desmoid tumors.
FDA posts a final guidance entitled Cover Letter Attachments for Controlled Correspondence and ANDA Submissions.
FDA posts a final guidance entitled Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals.
Federal Register notice: FDA makes available a final guidance entitled Drug-Drug Interaction (DDI) Assessment for Therapeutic Proteins.
Federal Register notice: FDA makes available a revised draft guidance entitled Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Developm...
