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FDA releases 89 previously unpublished complete response letters and says future letters will be released immediately after transmission to the sponso...
Medtronic Perfusion Systems recalls (Class 1) its DLP Left Heart Vent Catheters (malleable body and vented connector) because the devices may not reta...
FDA posts a drug complex innovative design case study for a higher dose of an alopecia areata drug that did not assign participants to a separate plac...
