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Week of Mar 24, 2025

›Mar 25, 2025approval524d ago

BLUJEPA (GEPOTIDACIN MESYLATE) — FDA approvalgepotidacin mesylate

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

›Mar 25, 2025approval524d agoCONEXXENCE (DENOSUMAB-BNHT) — FDA approvalCONEXXENCE

Sponsor: FRESENIUS KABI USA LLC. Form: INJECTION

›Mar 25, 2025approval524d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

›Mar 25, 2025device 510k524d agoBolt Medical, Inc. — Bolt Intravascular Lithotripsy (IVL) System (510k cleared)B. Braun Medical Inc

Product code: PPN. Advisory committee: Cardiovascular. Type: Traditional

›Mar 25, 2025device 510k524d agoInquis Medical — Aventus Thrombectomy System (IM-2100) (510k cleared)

Product code: QEW. Advisory committee: Cardiovascular. Type: Special