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...
FDA approves Janssens Darzalex Faspro (daratumumab and hyaluronidase-fihj) for adults with high-risk smoldering multiple myeloma (SMM), marking the fi...
Senate Democrats say they are worried that FDA and HHS may rely on partisan junk science during its recently announced review of the existing safety a...
