FDA cites SCA Pharmaceuticals for multiple deficiencies in sterile drug manufacturing practices following a 10-day inspection of the companys facility...
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...
FDA releases the form FDA-483 with five observations from a recent inspection of the UBI Pharma drug manufacturing facility in Hsinchu, Taiwan.
A new study shows that Eli Lillys investigational oral obesity drug helped patients largely maintain weight loss after transitioning off injectable in...
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...
FDA begins enforcement actions against companies illegally marketing breast binders to children, placing the agencys role at the center of a broader f...
During recent drug user fee negotiations on reauthorizing the PDUFA program, FDA officials and pharmaceutical industry representatives debate how far ...
FDA approves a new subcutaneous formulation of Johnson & Johnsons lung cancer drug amivantamab, allowing the therapy to be administered in minutes rat...
