House and Senate Democratic health leaders ask AstraZeneca, Lilly, Novo Nordisk, and Pfizer for details about the drug pricing deals the companies mad...
The CDER Office of Prescription Drug Promotion says a TV spot for Karuna Therapeutics Cobenfy is false or misleading in its description of the drugs u...
During recent drug user fee negotiations on reauthorizing the PDUFA program, FDA officials and pharmaceutical industry representatives debate how far ...
A new study shows that Eli Lillys investigational oral obesity drug helped patients largely maintain weight loss after transitioning off injectable in...
Regulators place a clinical hold on a pivotal lung cancer trial of ifinatamab deruxtecan after reports of treatment-related deaths from lung toxicity,...
FDA releases the form FDA-483 with five observations from a recent inspection of the UBI Pharma drug manufacturing facility in Hsinchu, Taiwan.
FDA begins enforcement actions against companies illegally marketing breast binders to children, placing the agencys role at the center of a broader f...
Novo Nordisk says it expects FDA to review in 2026 the companys NDA for CagriSema, an injectable once-weekly weight loss treatment combining Ozempic w...
