Federal Register notice: FDA makes available a final guidance entitled Clinical Pharmacology Considerations for Antibody-Drug Conjugates.
Federal Register: FDA announces a publication containing modifications the agency is making to the list of standards it recognizes for use in premarke...
FDA grants full approval to Johnson & Johnsons Rybrevant (amivantamab-vmjw) in combination with chemotherapy for the first-line treatment of certain p...
CDRHs Binita Ashar says a recent journal article on breast implant risk provided useful information for patients and providers about the need for caut...
FDA publishes a guidance to assist in the development of antibody-drug conjugates with a cytotoxic small-molecule drug or payload.
FDA commissioner Robert Califf says it is very difficult for states to meet the standards set by Congress for importing drugs from Canada.
FDA says it has received reports of rare adverse events involving electrical operating room tables.
A federal judge sentences former pharmacy compounder Patient Care America (PCA) CEO and president Patrick Smith to six months in prison for lying to f...
