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7,990 catalysts · 3,350 8k filing · 1,368 grant · 1,000 device adverse event · 615 approval · 582 earnings · 476 device 510k

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  • 8k filing3,350
  • grant1,368
  • device adverse event1,000
  • approval615
  • earnings582
  • device 510k476
  • device pma297
  • phase 2 completion172
  • drug shortage133
  • recall121
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Mar 9, 2026

    50
    ›Mar 11, 2026device pma158d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS PureSee IOL, Model DEN00V TECNIS PureSee Toric II IOLs, Model DET150, DET225, DET300, DET375 (PMA supplement)JOHNSON & JOHNSON

    Supplement type: Panel Track. Product code: HQL. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Mar 11, 2026device pma158d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3™ Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra™ Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra™ (PMA supplement)Edwards Lifesciences Corp

    Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Mar 11, 2026device pma158d agoEdwards Lifesciences, LLC — Edwards SAPIEN M3 Transcatheter Heart Valve (sizes 20mm, 23mm, 26mm, 29mm) (PMA supplement)Edwards Lifesciences Corp

    Supplement type: 30-Day Notice. Product code: NPU. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Mar 11, 2026device pma158d agoEdwards Lifesciences, LLC — INSPIRIS™ RESILIA™ Aortic Valve; KONECT RESILIA Aortic Valve Conduit (AVC); MITRIS RESILIA Mitral Valve (PMA supplement)Edwards Lifesciences Corp

    Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Mar 11, 2026device pma158d agoEdwards Lifesciences, LLC — Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process; Carpentier-Edwar (PMA supplement)Edwards Lifesciences Corp

    Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Mar 11, 2026device pma158d agoEdwards Lifesciences, LLC — Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process; Carpentier-Edwar (PMA supplement)Edwards Lifesciences Corp

    Supplement type: 30-Day Notice. Product code: DYE. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Mar 11, 2026device pma158d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3™ Transcatheter Heart Valve (PMA supplement)Edwards Lifesciences Corp

    Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Mar 11, 2026device pma158d agoMedtronic Vascular, Inc. — VenaSeal™ Closure System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: PJQ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Mar 11, 2026grant158d agoLEHIGH UNIVERSITY — 3D-Printed Scaffolds with Independently Tunable Multiscale Properties

    EB grant. $72,965. PI: Lesley W Chow

    full page →nih reporter ↗
    ›Mar 11, 2026grant158d agoDUKE UNIVERSITY — Geriatric oncology assessment to link with support for older women taking adj...Duke University

    CA grant. $668,691. PI: Gretchen Kimmick

    full page →nih reporter ↗
    ›Mar 11, 2026grant158d agoNEW JERSEY INSTITUTE OF TECHNOLOGY — Engineering an in vitro 3D tissue construct to study peripheral nerve regener...

    NS grant. $553,292. PI: Jonathan M. Grasman

    full page →nih reporter ↗
    ›Mar 11, 2026grant158d agoUNIVERSITY OF MICHIGAN AT ANN ARBOR — Novel Multi-targeted Strategies Targeting T-cell Lymphomas and their Microenv...

    CA grant. $646,920. PI: Ryan A Wilcox

    full page →nih reporter ↗
    ›Mar 11, 2026grant158d agoHARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH — Novel Methods for Joint Prediction in the presence of mortality

    HL grant. $43,560. PI: Stephanie Armbruster

    full page →nih reporter ↗
    ›Mar 11, 2026grant158d agoUNIVERSITY OF MISSOURI-COLUMBIA — Multimodal, Porous, Starfish-Like Soft Wearable Bioelectronic Systems for Mot...

    EB grant. $597,977. PI: Zheng Yan

    full page →nih reporter ↗
    ›Mar 11, 2026grant158d agoUTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH — PULSE (Program Understanding and Learning through Strategic Evaluation)University of Utah

    GM grant. $105,987. PI: Janet Iwasa

    full page →nih reporter ↗
    ›Mar 11, 2026grant158d agoLSU PENNINGTON BIOMEDICAL RESEARCH CTR — Breath Biomarkers of Disease and Health Outcomes (BREATHE OUT)

    GM grant. $225,000. PI: Jacob T Mey

    full page →nih reporter ↗
    ›Mar 12, 2026approval157d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

    Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Mar 12, 2026approval157d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

    Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Mar 12, 2026approval157d agoPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN HYDROBROMIDE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

    Sponsor: HETERO LABS LTD III. Form: SYRUP. Route: ORAL

    full page →PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE →fda approvals ↗
    ›Mar 12, 2026approval157d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

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

    full page →dulaglutide →fda approvals ↗
    ›Mar 12, 2026approval157d agoSOLIQUA 100/33 (INSULIN GLARGINE) — FDA approvalToujeo LA

    Sponsor: SANOFI-AVENTIS US. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →Toujeo LA →fda approvals ↗
    ›Mar 12, 2026approval157d agoPOTASSIUM PHOSPHATES (POTASSIUM PHOSPHATE, DIBASIC) — FDA approvalHospira Inc

    Sponsor: CAPLIN. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Mar 12, 2026approval157d agoFINGOLIMOD HYDROCHLORIDE — FDA approvalFINGOLIMOD HYDROCHLORIDE

    Sponsor: BIOCON LTD. Form: CAPSULE. Route: ORAL

    full page →FINGOLIMOD HYDROCHLORIDE →fda approvals ↗
    ›Mar 12, 2026approval157d agoFINGOLIMOD HYDROCHLORIDE — FDA approvalFINGOLIMOD HYDROCHLORIDE

    Sponsor: BIOCON LTD. Form: CAPSULE. Route: ORAL

    full page →FINGOLIMOD HYDROCHLORIDE →fda approvals ↗
    ›Mar 12, 2026approval157d agoADLYXIN (LIXISENATIDE) — FDA approvalADLYXIN

    Sponsor: SANOFI-AVENTIS US. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →ADLYXIN →fda approvals ↗
    ›Mar 12, 2026approval157d agoSUNLENCA (LENACAPAVIR SODIUM) — FDA approvallenacapavir sodium LA

    Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →lenacapavir sodium LA →fda approvals ↗
    ›Mar 12, 2026approval157d agoSUNLENCA (LENACAPAVIR SODIUM) — FDA approvallenacapavir sodium LA

    Sponsor: GILEAD SCIENCES INC. Form: TABLET. Route: ORAL

    full page →lenacapavir sodium LA →fda approvals ↗
    ›Mar 12, 2026approval157d agoPOMALIDOMIDE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Mar 12, 2026device 510k157d agoHsiner Co., Ltd. — VPAP Pediatric Face Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoInvera Medical — InVera Infusion Device (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoBionit Labs Srl — Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) (510k cleared)

    Product code: GXY. Advisory committee: Neurology. Type: Special

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoFree Flow Medical, Inc. — LungFlow Basket Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoGuangzhou Ajax Medical Equipment Co., Ltd. — Dental X-RAY Unit (AJX200) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoHR Healthcare — Liv Pre-lubricated Intermittent Catheter (510k cleared)HCA Healthcare, Inc.

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoA Cute Baby, Inc. — Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoDigestaid - Artificial Intelligence Development SA — Deep Capsule® (Deep Capsule US) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoProdeon Medical, Inc. — Urocross Expander System (Model Numbers ES2018 and ES3025) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoStryker Leibinger GmbH & Co KG — MEDPOR Customized Implant Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoAIRICU, Inc. — Medical Mesh Nebulizer (AirICU Max+) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoSpectrum Medical S.R.L. — Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoNanjing Mijo Technology Co., Ltd. — Power Mobility Scooter (MJMA01, MJMA02) (510k cleared)Nanjing Miracle Biotechnology Co Ltd

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoSpectrum Medical S.R.L. — Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoTermosalud S.L. — Zionic Pro Max (EMS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoZimmer, Inc. — Affixus Retrograde Femoral Nailing System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoMaterialise NV — Mimics Thoracic Planner (510k cleared)MATERIALISE NV

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoGenadyne Biotechnologies, Inc. — Genadyne ASTRA NPWT (510k cleared)POP Biotechnologies Inc

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoSignature Orthopaedics Pty, Ltd. — Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head (510k cleared)

    Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoMedtronic Minimed, Inc. — MiniMed Flex pump (510k cleared)Medtronic USA Inc

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoTyto Care , Ltd. — Tyto Stethoscope (G3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 12, 2026device 510k157d agoTrax Surgical, Inc. — Trax EX Anchor (510k cleared)

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

    full page →fda device 510k ↗
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    $NVS150.88-0.55%
    $NVS150.88-0.55%
    $LLY1180.16-2.25%
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    $EW91.33-2.47%
    $GILD138.36+0.16%
    $GILD138.36+0.16%
    $HCA404.68-1.71%
    $MTLS6.5600-1.06%