BioNTech and Duality Biologics report that trastuzumab pamirtecan met its primary endpoint in a pivotal Phase 3 trial for patients with HER2-positive ...
FDA extends by three months its review of Agios Pharmaceuticals supplemental NDA seeking to expand the use of Pyrukynd (mitapivat) to adults with thal...
FDA grants breakthrough therapy designation to Lillys oloromasib for certain lung cancers.
FDA releases the form FDA-483 containing 14 observations from an inspection at the GenoGenix outsourcing facility in Boca Raton, FL.
Sanofi says its investigational antibody amlitelimab met all primary and key secondary endpoints in a late-stage trial of patients with moderate-to-se...
Bipartisan criticism of Health and Human Services secretary Robert F. Kennedy Jr. dominates a contentious three-hour Senate Finance Committee hearing ...
FDA says an advisory committee is not needed to discuss the Aquestive NDA for Anaphylm to treat severe allergic reactions.
FDA releases 89 previously unpublished complete response letters and says future letters will be released immediately after transmission to the sponso...
