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20,185 catalysts · 4,728 grant · 3,126 8k filing · 3,102 device 510k · 2,791 approval · 2,000 device pma · 2,000 device recall

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  • grant4,728
  • 8k filing3,126
  • device 510k3,102
  • approval2,791
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall773
  • earnings583
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
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    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
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    Week of May 19, 2025

    50
    ›May 22, 2025approval447d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›May 22, 2025approval447d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

    full page →fda approvals ↗
    ›May 22, 2025approval447d agoKALYDECO (IVACAFTOR) — FDA approvalivacaftor

    Sponsor: VERTEX PHARMS INC. Form: GRANULE. Route: ORAL

    full page →ivacaftor →fda approvals ↗
    ›May 22, 2025approval447d agoISOTRETINOIN — FDA approvalZydus Therapeutics Inc

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

    full page →fda approvals ↗
    ›May 22, 2025approval447d agoTECHNESCAN PYP KIT (TECHNETIUM TC-99M PYROPHOSPHATE KIT) — FDA approval

    Sponsor: CURIUM. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›May 22, 2025approval447d agoTECHNESCAN HDP (TECHNETIUM TC-99M OXIDRONATE KIT) — FDA approval

    Sponsor: CURIUM. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›May 22, 2025approval447d agoLUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: ABBVIE ENDOCRINE INC. Form: POWDER. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›May 22, 2025approval447d agoEBGLYSS (LEBRIKIZUMAB-LBKZ) — FDA approvallebrikizumab

    Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION

    full page →lebrikizumab →fda approvals ↗
    ›May 22, 2025device 510k447d agoBasic Medical Technology, Inc. — Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k447d agoHua Yue Medical Technology Co., Ltd. — Harioculture TL-16 Time-lapse Incubator (510k cleared)NewBay Medical Technology Co Ltd

    Product code: MQG. Advisory committee: Obstetrics/Gynecology. Type: Traditional

    full page →fda device 510k ↗
    ›May 22, 2025device 510k447d agoUrotronic, Inc. — Optilume® High Pressure Urological Balloon Dilation Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k447d agoClinical Innovations, LLC — Koala Intrauterine Pressure Catheter (IPC-5000E) (510k cleared)

    Product code: HFN. Advisory committee: Obstetrics/Gynecology. Type: Traditional

    full page →fda device 510k ↗
    ›May 22, 2025device 510k447d agoTriMed, Inc. — TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k447d agoOrtho Development Corp. — Trivicta® Hip Stem (510k cleared)DeFi Development Corp.

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k447d agoCryoconcepts LP — Skin Clinic Freeze Point for Warts and Skin Tags (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k447d agoRandox Laboratories, Ltd. — ConcizuTrace™ ELISA (510k cleared)Rafa Laboratories Co Ltd

    Product code: SES. Advisory committee: Hematology. Type: Direct

    full page →fda device 510k ↗
    ›May 22, 2025device 510k447d agoArthrex, Inc. — Arthrex Spine Compression FT Screw (510k cleared)

    Product code: MRW. Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›May 22, 2025device 510k447d agoOvesco Endoscopy AG — ArgoCap (200.52) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k447d agoJiangsu Yuyue Medical Equipment & Supply Co., Ltd. — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k447d agoTerrats Medical SL — DESS Dental Smart Solutions (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k447d agoLima Corporate S.P.A. — Physica System (Physica CR Porous Femoral components) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 22, 2025device 510k447d agoThermo Fisher Scientific — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

    Product code: JWY. Advisory committee: Microbiology. Type: Traditional

    full page →fda device 510k ↗
    ›May 22, 2025device 510k447d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — Solawave 2-in-1 Skincare Mini (Model: 61043) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025approval446d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

    Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

    full page →nivolumab →fda approvals ↗
    ›May 23, 2025approval446d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2025approval446d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2025approval446d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2025approval446d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2025approval446d agoWAKIX (PITOLISANT HYDROCHLORIDE) — FDA approvalpitolisant hydrochloride

    Sponsor: HARMONY. Form: TABLET. Route: ORAL

    full page →pitolisant hydrochloride →fda approvals ↗
    ›May 23, 2025approval446d agoBOSUTINIB MONOHYDRATE — FDA approvalBOSUTINIB MONOHYDRATE

    Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

    full page →BOSUTINIB MONOHYDRATE →fda approvals ↗
    ›May 23, 2025approval446d agoOPDIVO QVANTIG (NIVOLUMAB) — FDA approval(hyaluronidase (recombinant, human) + nivolumab)

    Sponsor: BRISTOL-MYERS SQUIBB. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →(hyaluronidase (recombinant, human) + nivolumab) →fda approvals ↗
    ›May 23, 2025device 510k446d agoPearl, Inc. — Second Opinion® 3D (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoPiraeus Medical — 93 NeuFlex Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoKuros Biosciences B.V — MagnetOs MIS (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoGeske Beauty Tech GmbH — SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoShenzhen Ulike Smart Electronics Co., Ltd. — Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoLVIS Corporation — NeuroMatch (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoThe Binding Site Group , Ltd. — Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit (510k cleared)Dawn Sea Therapeutics

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoEizo Corporation — RadiForce MX317W-PA (510k cleared)

    Product code: PZZ. Advisory committee: Pathology. Type: Abbreviated

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoEwoosoft Co., Ltd. — Clever One (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoDepuy Ireland UC — RECLAIM Monobloc Revision Femoral Stem (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoEl Global Trade, Ltd. — IPL400 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoSpineup, Inc. — Frida™ Anterior Cervical Plate System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoWellell, Inc. — WiZARD 520 Full Face Mask (510k cleared)

    Product code: BZD. Advisory committee: Anesthesiology. Type: Traditional

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoABBOTT MEDICAL — ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoVenocare, Inc. — Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) (510k cleared)

    Product code: JKA. Advisory committee: Clinical Chemistry. Type: Traditional

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoDsi Dental Solutions, Ltd. — Sil-Flow (510k cleared)

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoRivanna Medical, Inc. — Accuro 3S (510k cleared)Vivani Medical, Inc.

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoBrain Navi Biotechnology Co., Ltd. — Stereotaxic Guiding Surgical Devices, NaoTrac S (510k cleared)Avistone Biotechnology Co Ltd

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

    full page →fda device 510k ↗
    ›May 23, 2025device 510k446d agoFujifilm Corporation — FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
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