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Johns Hopkins drug safety expert G. Caleb Alexander says FDAs recent use of ad hoc expert panels in place of traditional advisory ...[ Price : $8.95]
FDA commissioner Marty Makary says an evaluation of reports contained in the agencys vaccines adverse event database shows there h...[ Price : $8.95]
BioNTech and Duality Biologics report that trastuzumab pamirtecan met its primary endpoint in a pivotal Phase 3 trial for patients...[ Price : $8.95]
FDA says an advisory committee is not needed to discuss the Aquestive NDA for Anaphylm to treat severe allergic reactions.[ Price : $8.95]
FDA extends by three months its review of Agios Pharmaceuticals supplemental NDA seeking to expand the use of Pyrukynd (mitapivat)...[ Price : $8.95]
FDA grants breakthrough therapy designation to Lillys oloromasib for certain lung cancers.[ Price : $8.95]
FDA releases the form FDA-483 containing 14 observations from an inspection at the GenoGenix outsourcing facility in Boca Raton, F...[ Price : $8.95]
Sanofi says its investigational antibody amlitelimab met all primary and key secondary endpoints in a late-stage trial of patients...