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FDA Approval: New Drugs & Medical Devices

FDA Approval: New Drugs & Medical Devices

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NeoDrop Official
NeoDrop Official

Weekly FDA approvals of new drugs (NDA / BLA) and medical devices (510(k), PMA), with target indication and commercial impact

FDA Approval: New Drugs & Medical Devices
FDA Approval: New Drugs & Medical Devices
2026-10-30

FDA approvals: the first DNA medicine, Talzenna's earlier line and Ilumya in arthritis lead the Oct. 24–30 ledger

A date-bounded ledger of the FDA's October 24–30, 2026 decisions, led by the first DNA medicine approved in the United States, a PARP-inhibitor combination moved into hormone-sensitive prostate cancer, and an IL-23 antibody's first arthritis label.

FDA Approval: New Drugs & Medical Devices
FDA Approval: New Drugs & Medical Devices
2026-10-23

FDA approvals: Hibsago, Jemperli in rectal cancer and Awiqli for children lead the Oct. 17–23 ledger

A date-bounded ledger of the FDA's October 17–23, 2026 decisions, led by the first antisense drug approved for chronic hepatitis B, an accelerated approval that lets some dMMR rectal-cancer patients skip chemotherapy, radiation and surgery, and the first once-weekly insulin for children.

FDA Approval: New Drugs & Medical Devices
FDA Approval: New Drugs & Medical Devices
2026-10-16

FDA approvals: Enspryng, Anktiva and Alcon's over-the-counter eye drop lead the Oct. 9–16 ledger

A date-bounded ledger of the FDA's October 9–16, 2026 decisions, led by the first at-home subcutaneous treatment for thyroid eye disease, a bladder-cancer expansion that rests on extrapolated evidence, and the first nonprescription apraclonidine eye drop.

FDA Approval: New Drugs & Medical Devices
FDA Approval: New Drugs & Medical Devices
2026-10-09

FDA approvals: Hovilpri, Jaypirca and the Juveena hydrogel lead the Oct. 2–9 ledger

A date-bounded ledger of the FDA's October 2–9, 2026 decisions, led by the first drug approved for resistant herpes simplex lesions, a first-line CLL approval for pirtobrutinib, and the two original device approvals the agency's own feeds had only just begun to carry.

FDA Approval: New Drugs & Medical Devices
FDA Approval: New Drugs & Medical Devices
2026-10-02

FDA approvals: Emcitate, pediatric Camzyos and the Autus valve lead the Sep. 26–Oct. 2 ledger

A date-bounded ledger of the FDA's September 26–October 2, 2026 decisions, led by the first-ever approval for MCT8 deficiency, the first pediatric indication for a cardiac myosin inhibitor, and the first heart valve that can be widened as a child grows.

FDA Approval: New Drugs & Medical Devices
FDA Approval: New Drugs & Medical Devices
2026-09-25

FDA approvals: Atebrioz, Juvmo and Onswik lead the Sep. 19–25 ledger

A date-bounded review of four never-before-approved drugs — Atebrioz for fibrodysplasia ossificans progressiva, Juvmo for Parkinson's disease, Lyrfigtu for FGFR2-altered bile duct cancer, and Onswik, the second weekly insulin — plus Gazyva's first-in-class nephrotic syndrome indication, a new second-line kidney cancer regimen, and the captured FDA device ledger for September 19–25, 2026.

FDA Approval: New Drugs & Medical Devices
FDA Approval: New Drugs & Medical Devices
2026-09-18

FDA approvals: Fayuvi, Inluriyo and Bexlutry lead the Sep. 12–18 ledger

A date-bounded review of Fayuvi's first-ever gene therapy for Sanfilippo syndrome type A, Lilly's Inluriyo-Verzenio combination, Curium's radioligand equivalent Bexlutry, and the captured CDRH device ledger for September 12–18, 2026.

FDA Approval: New Drugs & Medical Devices
FDA Approval: New Drugs & Medical Devices
2026-09-11

Isembyld approval leads the Sep. 5–11 FDA drug and device ledger

A date-bounded weekly review of Scholar Rock's Isembyld approval for SMA, Drugs@FDA generic and supplemental actions, and the captured CDRH device clearance ledger.

FDA Approval: New Drugs & Medical Devices
FDA Approval: New Drugs & Medical Devices
2026-09-04

Zanvastro and Etcamah lead the Aug. 29–Sep. 4 FDA approval ledger

A date-bounded review of Zanvastro, Etcamah, generic and supplemental FDA drug actions, and the current gap in the public device ledger, with clinical and commercial context.

FDA Approval: New Drugs & Medical Devices
FDA Approval: New Drugs & Medical Devices
2026-08-28

FDA approvals: Rasonque, Lisraya and Bixlenvo lead the Aug. 21–28 ledger

A date-bounded review of three novel drugs, Gilead's Bixlenvo combination, major label expansions and the verified portion of the FDA device ledger for Aug. 21–28, 2026.

FDA Approval: New Drugs & Medical Devices
FDA Approval: New Drugs & Medical Devices
2026-08-22

FDA approvals: Pasatru, Genglycos and the Aletta blood-draw robot lead the Aug. 14–21 ledger

This week's verified FDA record is led by Pasatru for FOP, Genglycos for GSDIa, an autoinjector and kidney-label update, and the Aletta robotic blood-draw authorization, with device-ledger limits kept explicit.

FDA Approval: New Drugs & Medical Devices
FDA Approval: New Drugs & Medical Devices
2026-08-14

FDA approvals: Zenbexus, Saphnelo and MRESVIA lead the Aug. 7–14 ledger

This week’s FDA record is led by Zenbexus in relapsed multiple myeloma, a subcutaneous Saphnelo label expansion, and a pediatric safety update for MRESVIA, with device clearances separated as a lagging-ledger watchlist.

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