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15,048 catalysts · 3,603 8k filing · 2,723 grant · 2,426 approval · 1,714 device 510k · 1,264 device recall · 1,172 device pma

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  • 8k filing3,603
  • grant2,723
  • approval2,426
  • device 510k1,714
  • device recall1,264
  • device pma1,172
  • device adverse event1,000
  • earnings585
  • recall481
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Sep 29, 2025

    50
    ›Sep 29, 2025approval334d agoLAMOTRIGINE — FDA approvalZydus Pharmaceuticals USA Inc

    Sponsor: ZYDUS PHARMS USA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Sep 29, 2025approval334d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

    Sponsor: ZYDUS PHARMS USA INC. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Sep 29, 2025approval334d agoCALCIUM CHLORIDE 10% (CALCIUM CHLORIDE) — FDA approvalSquare Pharmaceuticals PLC

    Sponsor: SQUARE PHARMS PLC. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Sep 29, 2025approval334d agoDESIPRAMINE HYDROCHLORIDE — FDA approvalDESIPRAMINE HYDROCHLORIDE

    Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

    full page →DESIPRAMINE HYDROCHLORIDE →fda approvals ↗
    ›Sep 29, 2025approval334d agoTIZANIDINE HYDROCHLORIDE — FDA approvalTIZANIDINE HYDROCHLORIDE

    Sponsor: INGENUS PHARMS LLC. Form: CAPSULE. Route: ORAL

    full page →TIZANIDINE HYDROCHLORIDE →fda approvals ↗
    ›Sep 29, 2025approval334d agoIFOSFAMIDE — FDA approvalIFOSFAMIDE

    Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

    full page →IFOSFAMIDE →fda approvals ↗
    ›Sep 29, 2025device 510k334d agoSouth53, LLC — Primero Safe Access System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k334d agoBeta Bionics, Inc. — iLet ACE Pump (510k cleared)Beta Bionics, Inc.

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k334d agoSurgical Theater, Inc. — SpineAR SNAP (SyncAR Spine) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k334d agoLongfian Scitech Co., Ltd. — Portable oxygen concentrator (JAY-1000P) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k334d agoSonex Health — UltraGuideCTR® image guided soft tissue release system (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k334d agoHironic Co., Ltd. — NEW DOUBLO 2.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k334d agoPaltop Advanced Dental Solutions, Ltd. — Paltop Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k334d agoWilson-Cook Medical — SureTome™ SW Sphincterotome with DomeTip (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k334d agoGraphenano Dental S.L. — G-BLOCK (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k334d agoDisior, Ltd. — SMART PCFD (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k334d agoHager& Meisinger GmbH — Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device 510k334d agoTulavi Therapeutics, Inc. — allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) (510k cleared)Turn Therapeutics Inc.

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

    full page →fda device 510k ↗
    ›Sep 29, 2025device pma334d agoLungpacer Medical USA, Inc. — AeroPace® System (PMA supplement)

    Supplement type: Real-Time Process. Product code: SDL. Advisory committee: AN. Decision: APPR

    full page →fda device pma ↗
    ›Sep 29, 2025device pma334d agoPhysio-Control, Inc. — LIFEPACK® CR2 Automated External Defibrillator (AED) (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 29, 2025device pma334d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 29, 2025device pma334d agoZOLL Medical Corporation — ZOLL Zenix® Monitor/Defibrillator (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: MKJ. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Sep 29, 2025device pma334d agoHeartsine Technologies, Ltd. — HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) (PMA supplement)TAT TECHNOLOGIES LTD

    Supplement type: Real-Time Process. Product code: MKJ. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Sep 29, 2025device pma334d agoAbbott — CentriMag Circulatory Support System (PMA supplement)

    Supplement type: Real-Time Process. Product code: DSQ. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Sep 29, 2025device pma334d agoBard Peripheral Vascular, Inc. — LifeStream™ Balloon Expandable Vascular Covered Stent (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 29, 2025device pma334d agoInspire Medical Systems — Model 2740 Inspire Programmer; Model 2740S/C SleepSync Programming System (PMA supplement)Inspire Medical Systems, Inc.

    Supplement type: Real-Time Process. Product code: MNQ. Advisory committee: AN. Decision: APPR

    full page →fda device pma ↗
    ›Sep 29, 2025device recall334d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

    Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system — Reason: Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board. — Status: Ongoing

    full page →fda device recalls ↗
    ›Sep 29, 2025grant334d agoYALE UNIVERSITY — Optimizing Wolbachia-based interventions to ensure effective and equitable pr...

    AI grant. $49,538. PI: Elisabeth Nelson

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoUNIVERSITY OF WISCONSIN-MADISON — Understanding causes of autism, its heterogeneity, and rising prevalence with...

    OD grant. $1,697,492. PI: Amy Louise Cochran

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoEMORY UNIVERSITY — Mapping internal exposome-metabolome dynamics with advanced data science to i...Emory University

    OD grant. $3,996,872. PI: M Daniele Fallin

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoOREGON HEALTH & SCIENCE UNIVERSITY — Advancing Success & Developmental Outcomes in Autism Spectrum Disorder throug...

    OD grant. $4,249,998. PI: Margaret Gillis

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoBAYLOR COLLEGE OF MEDICINE — VALIDATE ASD: INDEPENDENT MULTIMODAL REPLICATION AND VALIDATION OF AUTISM DAT...Baylor College of Medicine

    OD grant. $4,853,391. PI: Ananth V Annapragada

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoUnknown institution — Bioactivity Assay Development Consulting Services

    DA grant. $10,000

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoCOLUMBIA UNIVERSITY HEALTH SCIENCES — A PHASE 2B STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS LEVONORG...

    HD grant. $24,882. PI: PAULA CASTAÑO

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoUnknown institution — Whole Genome Sequencing Diagnostics to Address Antibiotic Resistance

    AI grant. $1,000,000. PI: MATTHEW DAVIES

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoUnknown institution — BIOMEDICAL DATA TRANSLATOR USER INTERFACE DEVELOPMENT

    DA grant. $1,537,332. PI: ANDY CROUSE

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoUnknown institution — PHARMACEUTICS FORMULATION/CHEMISTRY MANUFACTURING AND CONTROLS CONSULTING SER...

    DA grant. $10,550

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoUnknown institution — PHARMACEUTICS FORMULATION/CHEMISTRY MANUFACTURING AND CONTROLS CONSULTING SER...

    DA grant. $54,000

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoUnknown institution — MEDICINAL CHEMISTRY CONSULTING SERVICES.

    DA grant. $9,000

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoSYZONC, LLC — SBIR FY25 CONCEPT AWARD, TARGETING PLOD2 IN UNDIFFERENTIATED PLEOMORPHIC SARCOMA

    CA grant. $354,878

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoUNIV OF NORTH CAROLINA CHAPEL HILL — From Data to Action: Capturing Meaningful Outcomes in Autism Through Harmoniz...

    OD grant. $4,283,587. PI: Laura G Klinger

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoWEILL MEDICAL COLL OF CORNELL UNIV — AR² - Autism Replication, Validation, and Reproducibility Center

    OD grant. $5,097,004. PI: RAINU KAUSHAL

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoUNIVERSITY OF TEXAS HLTH SCIENCE CENTER — Circadian reprogramming in cellular senescence

    AG grant. $75,052. PI: Kristi Ann Dietert

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoUnknown institution — PHARMACEUTICS FORMULATION/CHEMISTRY MANUFACTURING AND CONTROLS CONSULTING SER...

    DA grant. $16,000

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoSTATE UNIVERSITY OF NEW YORK AT BUFFALO — WOMEN'S HEALTH INITIATIVE (WHI) REGIONAL CENTER (RC): TASK AREA A AND A2

    HL grant. $1,236,673. PI: JEAN WACTAWSKI-WENDE

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoSTANFORD UNIVERSITY — WOMEN'S HEALTH INITIATIVE (WHI) REGIONAL CENTER (RC): TASK AREA A AND A2Stanford University

    HL grant. $1,121,018. PI: MARCIA STEFANICK

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoWAKE FOREST UNIVERSITY HEALTH SCIENCES — WOMEN'S HEALTH INITIATIVE (WHI) REGIONAL CENTER (RC): TASK AREA A AND A2Wake Forest University

    HL grant. $47,440. PI: MARA VITOLINS

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoEYDIS BIO, INC. — Discovery and Development of Oral Small-molecule Direct-acting AntiviralsEydis Bio Inc

    AI grant. $499,825. PI: SCOTT SCARNEO

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoBATTELLE CENTERS/PUB HLTH RES & EVALUATN — BIOLOGICS IDIQ TASK ORDER- NON-GLP TOXICITY AND TOXICOKINETIC STUDIES IN RODE...

    DA grant. $348,217

    full page →nih reporter ↗
    ›Sep 29, 2025grant334d agoVENTUREWELL — RADX INNOVATION FUNNEL FOR HEALTH TECHNOLOGIES - AWARD MANAGEMENT, TASK ORDER...

    HL grant. $1,529,606

    full page →nih reporter ↗
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