Roche says its investigational Brutons tyrosine kinase inhibitor fenebrutinib showed the strongest late-stage results yet reported for the drug class ...
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...
Fresenius Kabi recalls three lots of its famotidine injection after reserve samples from one lot tested out of specification for endotoxin levels.
A group of leaders from government, academia, and the pharmaceutical industry call for sweeping federal action to stabilize the U.S. drug supply, warn...
Cogent Biosciences reports positive data from a Phase 3 study of its KIT inhibitor bezuclastinib, saying that the drug combined with standard therapy ...
FDA cites Medispray Laboratories, a finished drug product manufacturer based in Ponda, Goa, India, for significant lapses in its quality control proce...
Intellia Therapeutics reports that a patient who experienced liver toxicity after being administered the companys CRISPR-based therapy nexiguran ziclu...
