Federal Register notice: FDA makes available a final guidance on compounding certain ibuprofen oral suspension products.
Federal Register notice: FDA announces two public meetings on electronic submission of adverse event reports using International Council for Harmoniza...
GE HealthCare recalls its Nuclear Medicine 600 and 800 Series systems after identifying an issue with two mechanisms that prevent uncontrolled detecto...
UK-based researchers say their analysis of drug company financial records doesnt support company claims that high drug prices are needed to support re...
FDA commissioner Robert Califf outlines ways the agency is taking additional steps as part of its response to the nations opioid crisis.
FDA releases a batch of 30 new and revised product-specific guidances to aid in the development of generic drugs.
Pfizer says FDA has granted priority review for its sNDA for Talzenna and Xtandi which showed positive results in a Phase 3 study for treating metasta...
FDA approves a BioVex BLA supplement to update the adverse drug reactions for its talimogene laherparepvec melanoma treatment.
