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21,466 catalysts · 4,728 grant · 3,940 device 510k · 3,100 approval · 3,086 8k filing · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 57 catalysts2026-08-12: 19 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 2 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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  • grant4,728
  • device 510k3,940
  • approval3,100
  • 8k filing3,086
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall947
  • earnings583
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jan 20, 2025

    29
    ›Jan 23, 2025approval566d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

    Sponsor: ABBVIE. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

    full page →divalproex sodium DR →fda approvals ↗
    ›Jan 23, 2025approval566d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

    Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →divalproex sodium DR →fda approvals ↗
    ›Jan 23, 2025approval566d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

    Sponsor: ABBVIE. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →divalproex sodium DR →fda approvals ↗
    ›Jan 23, 2025approval566d agoLISDEXAMFETAMINE DIMESYLATE — FDA approvalLISDEXAMFETAMINE DIMESYLATE

    Sponsor: ASCENT PHARMS INC. Form: CAPSULE. Route: ORAL

    full page →LISDEXAMFETAMINE DIMESYLATE →fda approvals ↗
    ›Jan 23, 2025device 510k566d agoShenzhen Launch Electrical Co., Ltd. — Rotatable Connector (5944RL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k566d agoZhejiang Seedream Medical Equipment Co., Ltd. — Mobility Scooter (S-01); Mobility Scooter (S-02) (510k cleared)

    Product code: INI. Advisory committee: Physical Medicine. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k566d agoOts Medical , Ltd. — OTS 25-L (100-5) (510k cleared)KAHR medical Ltd

    Product code: MBI. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k566d agoShanghai Samedical & Plastic Instruments Co., Ltd. — RF Cannula (510k cleared)

    Product code: GXI. Advisory committee: Neurology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k566d agoLife Spine, Inc. — ProLift Pivot Expandable Spacer System (510k cleared)

    Product code: MAX. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k566d agoAcumed, LLC — Acu-Sinch Knotless Mini (510k cleared)

    Product code: HTN. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k566d agoCyncronus, LLC — CephNinja (510k cleared)

    Product code: LLZ. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k566d agoTerarecon,Inc. — TeraRecon Aorta.CT (1.1.0) (510k cleared)

    Product code: QIH. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k566d agoMurata Vios, Inc. — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k566d agoAuris Health, Inc. — MONARCH™ Platform (MON-000008) (510k cleared)

    Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 24, 2025approval565d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Jan 24, 2025approval565d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Jan 24, 2025approval565d agoLEQEMBI (LECANEMAB-IRMB) — FDA approvallecanemab

    Sponsor: EISAI INC. Form: INJECTABLE. Route: INJECTION

    full page →lecanemab →fda approvals ↗
    ›Jan 24, 2025approval565d agoAVTOZMA (TOCILIZUMAB-ANOH) — FDA approvalAVTOZMA

    Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INTRAVENOUS

    full page →AVTOZMA →fda approvals ↗
    ›Jan 24, 2025device 510k565d agoBridge TO Life, Ltd. — OrganProtex HTK Solution (510k cleared)

    Product code: KDL. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k565d agoIndiba S. A. U. — Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) (510k cleared)

    Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k565d agoRoche Diagnostics Operations — Tina-quant Lipoprotein(a) Gen.2 Molarity (510k cleared)Dawn Sea Therapeutics

    Product code: DFC. Advisory committee: Immunology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k565d agoZhejiang Curaway Medical Technology Co., Ltd. — Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

    Product code: KNW. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k565d agoElliquence, LLC — AxCess® Expandable Interbody System (510k cleared)

    Product code: MAX. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k565d agoZhejiang Curaway Medical Technology Co., Ltd. — Bone Marrow Biopsy Needle (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

    Product code: KNW. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k565d agoClearPoint Neuro, Inc. — ClearPoint System (Software Version 3.0) (510k cleared)ClearPoint Neuro, Inc.

    Product code: HAW. Advisory committee: Neurology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k565d agoIbex Medical Analytics , Ltd. — Galen™ Second Read™ (510k cleared)

    Product code: QPN. Advisory committee: Pathology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k565d agoMagentiq Eye, Ltd. — MAGENTIQ-COLO (ME-APDS) (510k cleared)

    Product code: QNP. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k565d agoWuhan Guangdun Technology Co.,Ltd.. — Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) (510k cleared)

    Product code: NHN. Advisory committee: Physical Medicine. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 26, 2025approval563d agoNIZORAL ANTI-DANDRUFF (KETOCONAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: KRAMER. Form: SHAMPOO. Route: TOPICAL

    full page →fda approvals ↗

    Week of Jan 27, 2025

    21
    ›Jan 27, 2025approval562d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

    Sponsor: TORRENT PHARMS. Form: TABLET, CHEWABLE. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Jan 27, 2025approval
    ← prev
    page 2 of 430
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    562d ago
    CARBAMAZEPINE — FDA approvalcarbamazepine ER

    Sponsor: TORRENT PHARMS. Form: TABLET. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Jan 27, 2025approval562d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

    Sponsor: TORRENT PHARMS. Form: TABLET. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Jan 27, 2025approval562d agoENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) — FDA approvaltrastuzumab deruxtecan

    Sponsor: DAIICHI SANKYO. Form: INJECTABLE. Route: INJECTION

    full page →trastuzumab deruxtecan →fda approvals ↗
    ›Jan 27, 2025approval562d agoENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) — FDA approvaltrastuzumab deruxtecan

    Sponsor: DAIICHI SANKYO. Form: INJECTABLE. Route: INJECTION

    full page →trastuzumab deruxtecan →fda approvals ↗
    ›Jan 27, 2025device 510k562d agoBeijing Sano Laser S&T Development Co.,Ltd — CO2 Laser Therapy Systems (SHE-LSP003-1) (510k cleared)

    Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 27, 2025device 510k562d agoFirstar Dental Company — Firstar Dental Unit (510k cleared)

    Product code: EIA. Advisory committee: Dental. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 27, 2025device 510k562d agoMedical Microinstruments, Inc. — Symani Surgical System (820-03830) (510k cleared)

    Product code: SAQ. Advisory committee: General, Plastic Surgery. Type: Special

    full page →fda device 510k ↗
    ›Jan 27, 2025device 510k562d agoRaysolution Healthcare Co., Ltd. — Imaging system of positron emission and X-ray computed tomography (DigitMI 930) (510k cleared)

    Product code: KPS. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 27, 2025device 510k562d agoBunkerHill Health — Bunkerhill AVC (510k cleared)

    Product code: JAK. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 28, 2025approval561d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

    Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

    full page →pembrolizumab →fda approvals ↗
    ›Jan 28, 2025approval561d agoEPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

    Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION

    full page →EPYSQLI →fda approvals ↗
    ›Jan 28, 2025approval561d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Jan 28, 2025device 510k561d agoShenzhen Rainbow Technology Co., Ltd. — LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

    Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k561d agoBrainlab AG — Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT (510k cleared)

    Product code: HAW. Advisory committee: Neurology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k561d agoHuxley Medical — SANSA HSAT (510k cleared)

    Product code: MNR. Advisory committee: Anesthesiology. Type: Special

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k561d agoConmed Corporation — Argo Knotless GENESYS Anchor (510k cleared)CONMED Corp

    Product code: MBI. Advisory committee: Orthopedic. Type: Special

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k561d ago3M Company — 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M (510k cleared)3M CO

    Product code: FRC. Advisory committee: General Hospital. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k561d agoInstrumentation Laboratory (IL) Co. — HemosIL CL HIT-IgG(PF4-H) (510k cleared)

    Product code: LCO. Advisory committee: Hematology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 28, 2025device 510k561d agoLg Electronics.Inc — Medical Monitor (27HS714S) (510k cleared)ARROW ELECTRONICS, INC.

    Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 29, 2025approval560d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

    Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    $ABBV247.97+0.78%
    $ABBV247.97+0.78%
    $NVS156.79+0.29%
    $ABBV247.97+0.78%
    $CLPT
    $NVS156.79+0.29%
    $MMM
    $FRTRY
    $CNMD32.58+1.46%
    $ARW226.78+1.76%