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12,161 catalysts · 3,603 8k filing · 2,283 grant · 1,765 approval · 1,146 device 510k · 1,000 device adverse event · 827 device pma

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  • 8k filing3,603
  • grant2,283
  • approval1,765
  • device 510k1,146
  • device adverse event1,000
  • device pma827
device recall
606
  • earnings585
  • recall266
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Dec 15, 2025

    50
    ›Dec 19, 2025approval253d agoMYQORZO (AFICAMTEN) — FDA approvalaficamten

    Sponsor: CYTOKINETICS. Form: TABLET. Route: ORAL

    full page →aficamten →fda approvals ↗
    ›Dec 19, 2025approval253d agoMOUNJARO (TIRZEPATIDE) — FDA approvalZEPBOUND

    Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →ZEPBOUND →fda approvals ↗
    ›Dec 19, 2025approval253d agoDECITABINE — FDA approvalDECITABINE

    Sponsor: RELIANCE LIFE SCI. Form: INJECTABLE. Route: INTRAVENOUS

    full page →DECITABINE →fda approvals ↗
    ›Dec 19, 2025approval253d agoLUNSUMIO (MOSUNETUZUMAB-AXGB) — FDA approvalmosunetuzumab

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

    full page →mosunetuzumab →fda approvals ↗
    ›Dec 19, 2025approval253d agoREZDIFFRA (RESMETIROM) — FDA approvalresmetirom

    Sponsor: MADRIGAL. Form: TABLET. Route: ORAL

    full page →resmetirom →fda approvals ↗
    ›Dec 19, 2025approval253d agoREZDIFFRA (RESMETIROM) — FDA approvalresmetirom

    Sponsor: MADRIGAL. Form: TABLET. Route: ORAL

    full page →resmetirom →fda approvals ↗
    ›Dec 19, 2025approval253d agoREZDIFFRA (RESMETIROM) — FDA approvalresmetirom

    Sponsor: MADRIGAL. Form: TABLET. Route: ORAL

    full page →resmetirom →fda approvals ↗
    ›Dec 19, 2025approval253d agoJASCAYD (NERANDOMILAST) — FDA approvalnerandomilast

    Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

    full page →nerandomilast →fda approvals ↗
    ›Dec 19, 2025approval253d agoBONCRESA (DENOSUMAB-MOBZ) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: AMNEAL PHARMS LLC. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Dec 19, 2025approval253d agoOZILTUS (DENOSUMAB-MOBZ) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: AMNEAL PHARMS LLC. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Dec 19, 2025approval253d agoFLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) — FDA approvalGlaxoSmithKline LLC

    Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

    full page →fda approvals ↗
    ›Dec 19, 2025approval253d agoBYLVAY (ODEVIXIBAT) — FDA approvalodevixibat

    Sponsor: IPSEN. Form: CAPSULE. Route: ORAL

    full page →odevixibat →fda approvals ↗
    ›Dec 19, 2025approval253d agoACCRUFER (FERRIC MALTOL) — FDA approvalferric maltol

    Sponsor: SHIELD TX. Form: CAPSULE. Route: ORAL

    full page →ferric maltol →fda approvals ↗
    ›Dec 19, 2025approval253d agoFLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) — FDA approvalParatek Pharmaceuticals Inc

    Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

    full page →fda approvals ↗
    ›Dec 19, 2025approval253d agoZINGO (LIDOCAINE HYDROCHLORIDE) — FDA approvalPowder Pharmaceuticals Inc

    Sponsor: POWDER PHARMS. Form: SYSTEM. Route: INTRADERMAL

    full page →fda approvals ↗
    ›Dec 19, 2025device 510k253d agoHeartLung Corporation — AI-CVD (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoParagon 28, Inc. — Monkey Rings External Ring Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoMedskin Solutions Dr. Suwelack AG — MatriDerm pluS+ Bi-Layer (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoStryker GmbH — Hoffmann LRF System (510k cleared)STRYKER CORP

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoSorin Group Italia S.R.L. — ProtekDilate Vascular Access Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoGm Dos Reis Industria E Comercio — Pectus Versa System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoCathegenix (Xiamen) Co., Ltd. — Endura™ Ureteral Stent and Stent Set (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoCapsoVision, Inc. — CE Deliver (DLV) (510k cleared)CapsoVision, Inc

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoOconnell Regulatory Consultants, Inc. — Vivo 45 LS (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoDiabeloop — DBLG2 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoSciton, Inc — JOULE 1064nm System and Accessories (510k cleared)Aston Sci Inc

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoMedtronic, Inc. — C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoMikron Makina Sanayi VE Tic. Ltd. Sti. — MSFX MIKRON PEEK CAGES (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoLeadoptik, Inc. — LIA-1 Catheter (542-1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoDiazyme Laboratories, Inc. — Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay (510k cleared)Dolby Laboratories, Inc.

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoRhythm AI, Ltd. — STAR Apollo™ Mapping System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoQingdao Bright Moon Biomedical Materials Co., Ltd. — Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoWontech Co., Ltd. — SANDRO Dual (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoTruvian Health — Tru Liver Health Test Panel (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoTOPIA MEDTECH LIMITED — Alzevita (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoSouthern Medical (Pty) , Ltd. — Southern Craniomaxillofacial (CMF) System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoKulzer, LLC — iCEM Universal Plus (510k cleared)

    Product code: EMA. Advisory committee: Dental. Type: Abbreviated

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoSurgical Instrument Service and Savings, Inc. — Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoSunglor Technology Co., Ltd. — LED Light Therapy Device (Models: SG-FM, SG-FE) (510k cleared)Viomi Technology Co., Ltd

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoCsd Labs — eMurmur Heart AI (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoFisher & Paykel Healthcare, Ltd. — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoUnipack, LLC — Chiavaye Personal Moisturizer (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoOrtho Development Corp. — Balanced Knee System TriMax Porous Femoral Components (510k cleared)DeFi Development Corp.

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoEncore Medical L.P. — EMPOWR Knee (510k cleared)Encore Medical, Inc.

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoLeadoptik, Inc. — LIA Console (542-7) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoMerit Medical Systems, Inc. — SCOUT MD Surgical Guidance System (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoRadformation, Inc. — ClearCalc Model RADCA V2.6 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoShenzhen Beacon Display Technology Co., Ltd. — LCD Monitor (CL1902A, CL2103F) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoGuangdong Youmeng Electrical Technology Co., Ltd. — Wearable Electric Breast Pump (YM-8803) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 19, 2025device 510k253d agoPoskom Co., Ltd. — Airbile-100 (510k cleared)

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

    full page →fda device 510k ↗
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    page 13 of 244
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    $CYTK72.09-7.46%
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    $AMRX17.54-2.61%
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    $MDGL543.69+0.89%
    $MDT91.23+1.40%
    $CV
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    $AMRX17.54-2.61%
    $SYK330.69+2.66%
    $DLB
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