FDA publishes a final rule rolling back a 2024 regulation that expanded the agencys authority over laboratory-developed tests.
FDA approves an AstraZeneca supplemental NDA for Airsupra (albuterol/budesonide) to expand the drugs labeling to reflect a 46% reduction of severe exa...
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.
FDA issues a draft guidance revising and updating a 2013 guidance on safety labeling changes when new safety information becomes available after a dru...
