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FDA issues a revised draft guidance on covariate adjustment in some drug and biologic clinical trials.
FDA issues a draft guidance responding to additional questions about FDA-1572.
Federal Register notice: FDA makes available a final guidance entitled ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to...
FDA issues a guidance with its recommendations on testing to assess medical device safety and compatibility in the magnetic resonance environment.
FDA says the impact of Covid-19 on companies will result in a two-year extension of enforcement discretion of the regulation prohibiting the use of le...