FDA approves Mercks pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for subcutaneous injection for adult and pediatric solid tumor indic...
FDA escalates medical device oversight this year, issuing more Warning Letters and relying on artificial intelligence to zero-in on compliance gaps, a...
FDA publishes a final rule rolling back a 2024 regulation that expanded the agencys authority over laboratory-developed tests.
Regeneron says it will submit an application to FDA by the end of 2025 seeking approval for its garetosmab to treat adults with fibrodysplasia ossific...
Three Sidley attorneys suggest ways drug companies can take advantage of the flexibility in FDAs guidance on using alternative tools for facility eval...
FDA issues an alert after becoming aware that Abbott issued a letter to customers recommending updated instructions when removing the TactiFlex Ablati...
FDA releases the form FDA-483 with six observations from an inspection at Wichita, KS-based Fagron Compounding Services.
FDA approves Biocon Biologics biosimilars for Amgens Prolia and Xgeva.