FDA says it will begin removing broad boxed warnings from menopause-related hormone replacement therapy products based on a recent safety review.
A group of leaders from government, academia, and the pharmaceutical industry call for sweeping federal action to stabilize the U.S. drug supply, warn...
FDA cites Alvotechs Reykjavik, Iceland, manufacturing site for widespread sterility assurance, environmental monitoring, and quality-system failures f...
Merck reports positive Phase 3 results for its oral PCSK9 inhibitor enlicitide, showing LDL-cholesterol reductions approaching 60% with a safety profi...
Roche says its investigational Brutons tyrosine kinase inhibitor fenebrutinib showed the strongest late-stage results yet reported for the drug class ...
Cogent Biosciences reports positive data from a Phase 3 study of its KIT inhibitor bezuclastinib, saying that the drug combined with standard therapy ...
Fresenius Kabi recalls three lots of its famotidine injection after reserve samples from one lot tested out of specification for endotoxin levels.
FDA cites Medispray Laboratories, a finished drug product manufacturer based in Ponda, Goa, India, for significant lapses in its quality control proce...
