FDA grants a Center for Responsible Science petition to the extent that the agency no longer requires or recommends Draize dermal or ocular tests as p...
AdvaMed gives FDA a 14-page table with 44 suggested edits to a draft guidance on the characterization of metallic coatings and/or calcium phosphate co...
FDA approves safety labeling changes for fluorouracil injection products when used in patients with dihydropyrimidine dehydrogenase deficiency.
Vyaire Medical recalls certain AirLife Manual Resuscitators due to a manufacturing defect.
A House Energy and Commerce Health Subcommittee hearing discusses the need to legislatively reform FDAs oversight of laboratory-developed tests instea...
Merck says its Phase 3 KEYLYNK-006 trial evaluating Keytruda (pembrolizumab) in combination with maintenance Lynparza (olaparib) did not meet its prim...
Abiomed recalls its Impella Left Sided Blood Pumps because the pump catheter may slice the hearts left ventricle wall during procedures.
FDA grants Elixir Medical a breakthrough device designation for its DynamX BTK System, an adaptive implant for use in treating narrowed or blocked ves...
