FDA grants Vor Biopharma a fast track designation for VOR33, Vors engineered hematopoietic stem cell therapeutic candidate for treating acute myeloid ...
Federal Register notice: FDA reopens the comment period for public scoping on the environmental impact statement described in the notice entitled Inte...
CDERs Office of Prescription Drug Promotion proposes to examine whether disclosures in direct-to-consumer and healthcare provider-targeted advertising...
FDA announces a 9/23 symposium entitled FDA-PDS Symposium X Data Sharing; The Future of Clinical Trial Data SharingThe Art of the Possible.
FDA says it has initiated on-site inspections at Philips Respironics manufacturing facilities to assess compliance with regulatory requirements follow...
Federal Register notice: FDA announces a public workshop entitled Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mi...
FDA grants breakthrough therapy designation to Boehringer Ingelheim and Lillys Jardiance for treating heart failure with preserved ejection fraction.
Federal Register notice: FDA makes available a draft guidance entitled S12 Nonclinical Biodistribution Considerations for Gene Therapy Products.