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FDA issues Pfizer and OPKO Health a complete response letter for their BLA for somatrogon, an investigational once-weekly long-act...[ Price : $8.95]
FDA launches a REMS Public Dashboard to improve data access and transparency.[ Price : $8.95]
Five stakeholders give FDA their recommendations for changes to its proposed rule to establish a regulatory category for OTC heari...[ Price : $8.95]
Federal Register notice: FDA seeks comments on its proposal to classify human leukocyte antigen, human platelet antigen, and human...[ Price : $8.95]
Federal Register notice: FDA classifies retinal diagnostic software devices into Class 2 (special controls).[ Price : $8.95]
FDA commissioner nominee Robert Califf says ways must be found to speed confirmatory trials for drugs given accelerated approval.[ Price : $8.95]
FDA places a clinical hold on Dyne Therapeutics IND for a trial of Dyne-251 to treat Duchenne muscular dystrophy.[ Price : $8.95]
FDA sends Aurobindo Pharma a Warning Letter over GMP deficiencies cited 8/2021 at its Hyderabad, India-based Unit 1 active pharmac...