Vyaire Medical recalls (Class 1) its Vyaire Twin Tube sample line 240 cm, Model Number V-707327, which is used in the companys Vyntus CPX cardiopulmon...
RAPT Therapeutics closes and unblinds two Phase 2 trials of zelnecirnon following FDA clinical holds due to liver failure in one patient reported earl...
BIO asks FDA to hold more discussions on a draft guidance on collecting racial and ethnicity data in clinical trials and studies.
DuVal & Associates asks the Supreme Court to hear an appeal of a 1st Circuit Court of Appeals decision upholding the conviction of two former Acclaren...
During a Senate Appropriations hearing, FDA commissioner Robert Califf tells lawmakers that the agency is advising against enriched enrollment studies...
FDA accepts for review a Bristol Myers Squibb BLA for a subcutaneous formulation of Opdivo (nivolumab) across all previously approved adult solid tumo...
FDA publishes a final guidance to clarify the distinctions between medical device remanufacturing and servicing.
A BMJ investigation looks at the relationship between several FDA commissioners and the companies the agency regulates.
