Two Hyman, Phelps attorneys say the VALID bill contains what appears to be an inadvertent provision that could adversely affect telehealth testing of ...
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 ...