FDA accepts for priority review a BeiGene supplemental NDA for Brukinsa (zanubrutinib) for treating adult patients with marginal zone lymphoma.
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide bioequivalence study design re...
Federal Register notice: FDA makes available a final guidance on Testing and labeling medical devices as MRI-safe.
CDRH announces research efforts it will undertake to address scientific knowledge gaps in host responses to an implanted metal device, including adver...
FDA approves a Janssen Pharmaceutical NDA for Rybrevant (amivantamab-vmjw) for treating adult patients with non-small cell lung cancer whose tumors ha...
Boston Scientific recalls its VICI SDS and RDS Venous Stent Systems after receiving reports indicating the devices may migrate or move from where they...
FDA officials describe how the Covid-19 pandemic led to quicker and greater acceptance of real-world data/evidence.
FDA issues a revised draft guidance on covariate adjustment in some drug and biologic clinical trials.