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FDA issues a draft guidance revising and updating a 2013 guidance on safety labeling changes when new safety information becomes available after a dru...
The House Energy and Commerce Committee unanimously approves legislation to reauthorize FDAs Rare Pediatric Disease Priority Review Voucher program.
FDA publishes a final rule rolling back a 2024 regulation that expanded the agencys authority over laboratory-developed tests.
FDA publishes a draft guidance to help sponsors with clinical trials for drugs to treat disseminated coccidiomycosis.
Eli Lilly reports that it oral diabetes drug orforglipron achieved stronger blood sugar and weight loss results than Novo Nordisks oral semaglutide in...
