FDA approves a Fresenius Kabi BLA for Idacio (adalimumab-aacf), a biosimilar product referencing AbbVies Humira (adalimumab).
A Massachusetts federal judge sentences the former New England Compounding Center operations director to five months in jail for conspiring to defraud...
FDA clears a Life Spine 510(k) for the TruLift Lateral Expandable Spacer System and Lateral Plate System for use in lateral lumbar interbody fusions.
FDAs Cardiovascular and Renal Drugs Advisory Committee votes 8 to 3 against recommending approval of Cytokinetics omecamtiv mecarbil for treating hear...
Federal Register notice: FDA announces the two-year renewal of its Endocrinologic and Metabolic Drugs Advisory Committee.
Federal Register notice: FDA announces that a priority review voucher was redeemed in the 5/23 approval of United Therapeutics supplemental NDA for Ty...
A Kaiser Health News report says four states have now submitted applications to import some drugs from Canada, with others signaling interest but not ...
FDA accepts for review an Eyenovia resubmitted NDA for MydCombi ophthalmic spray, a drug-device combination product that comprises tropicamide and phe...
