Pharmaceutical Research and Manufacturers of America calls on FDA to harmonize drug direct manufacturing and point-of-care manufacturing regulation wi...
AdvaMed says it strongly supports FDA efforts to update a guidance on the breakthrough devices program.
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.
