FDAs Los Angeles District Office warns B. Braun Medical about repeat CGMP violations at its Irvine, CA, drug manufacturing facility.
FDAs Los Angeles District Office warns Med-Pharmex about CGMP violations in its production of animal drugs.
Belcher Pharmaceuticals petitions FDA to revise its epinephrine product sulfite warning to acknowledge that the companys sulfite-free epinephrine inje...
Officials of FDA and its European and Japanese counterparts agree to work toward harmonizing clinical study requirements for antibacterial agents for ...
FDA denies without comment a Mallinckrodt petition seeking changes with regard to applications referencing the companys Inomax nitric oxide product.
A RealClear Health columnist calls on Congress to enact policies that promote drug innovation and change FDAs focus from drug and device approval to p...
FDA says a Zimmer Biomet recall of implantable spinal fusion stimulators is Class 1.
FDA approves the expanded use of Novartis Zykadia (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung canc...