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21,894 catalysts · 4,728 grant · 4,110 device 510k · 3,288 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 118 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 3 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 510k4,110
  • 8k filing3,288
  • approval3,118
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall985
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Mar 24, 2025

    23
    ›Mar 27, 2025device 510k505d agoHeadsafe Mfg Pty, Ltd. — Nurochek-Pro System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 28, 2025approval504d agoPLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — FDA approvallutetium Lu 177 vipivotide tetraxetan

    Sponsor: NOVARTIS. Form: SOLUTION. Route: INTRAVENOUS

    full page →lutetium Lu 177 vipivotide tetraxetan →fda approvals ↗
    ›Mar 28, 2025approval504d agoPLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — FDA approvallutetium Lu 177 vipivotide tetraxetan

    Sponsor: NOVARTIS. Form: SOLUTION. Route: INTRAVENOUS

    full page →lutetium Lu 177 vipivotide tetraxetan →fda approvals ↗
    ›Mar 28, 2025approval504d agoABILIFY MAINTENA KIT (ARIPIPRAZOLE) — FDA approvalaripiprazole LA

    Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

    full page →aripiprazole LA →fda approvals ↗
    ›Mar 28, 2025approval504d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Mar 28, 2025approval504d agoBRIXADI (BUPRENORPHINE) — FDA approvalbuprenorphine LA

    Sponsor: BRAEBURN. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS

    full page →buprenorphine LA →fda approvals ↗
    ›Mar 28, 2025approval504d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Mar 28, 2025approval504d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

    Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Mar 28, 2025approval504d agoADZENYS XR-ODT (AMPHETAMINE) — FDA approvalTraws Pharma, Inc.

    Sponsor: NEOS THERAPS. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Mar 28, 2025device 510k504d agoMedphoton GmbH — ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k504d agoSiemens Healthcare Diagnostic Products GmbH — INNOVANCE Antithrombin (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k504d agoWuxi Jiajian Medical Instrument Co., Ltd. — Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k504d agoBeckman Coulter, Inc. — Access Toxo IgG (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k504d agoConvatec — Flexi-Seal AIR (with ENFit Connector) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k504d agoArthrex, Inc. — Arthrex FiberTak Suture Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k504d agoMakani Science, Inc. — Makani Science™ Respiration Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k504d agoTuring Medical Technologies, Inc. — Bullsai Confirm (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k504d agoSmith & Nephew, Inc. — CATALYSTEM Femoral Stems (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k504d agoSynthes GmbH — Synthes Graphic Case & Tray System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k504d agoSelux Diagnostics, Inc. — PBC Separator with Selux AST System (510k cleared)Co-Diagnostics, Inc.

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

    full page →fda device 510k ↗
    ›Mar 28, 2025device 510k504d agoVisby Medical, Inc. — Visby Medical Women's Sexual Health Test (510k cleared)Vivani Medical, Inc.

    Product code: SEA. Advisory committee: Microbiology. Type: Direct

    full page →fda device 510k ↗
    ›Mar 30, 2025device 510k502d agoAlpha Omega Engineering , Ltd. — Neuro Omega System; NeuroSmart System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 30, 2025device 510k502d agoPrecision Neuroscience, Corp. — Layer 7-T (510k cleared)

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

    full page →fda device 510k ↗

    Week of Mar 31, 2025

    27
    ›Mar 31, 2025approval501d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

    Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

    full page →DOXYCYCLINE HYCLATE →fda approvals ↗
    ›Mar 31, 2025approval
    ← prev
    page 23 of 438
    next →
    501d ago
    DOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

    Sponsor: AMNEAL. Form: TABLET. Route: ORAL

    full page →DOXYCYCLINE HYCLATE →fda approvals ↗
    ›Mar 31, 2025approval501d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

    Sponsor: HIKMA INTL PHARMS. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Mar 31, 2025approval501d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

    Sponsor: MYLAN. Form: TABLET. Route: ORAL

    full page →DOXYCYCLINE HYCLATE →fda approvals ↗
    ›Mar 31, 2025approval501d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: ALVOGEN. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Mar 31, 2025approval501d agoPYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

    Sponsor: LABS JUVISE. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Mar 31, 2025device 510k501d agoTribusmed Beheer BV — TribusConnect (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 31, 2025device 510k501d agoShantou Institute of Ultrasonic Instruments Co., Ltd. — Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 31, 2025device 510k501d agoTaewoong Medical Co., Ltd. — Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 31, 2025device 510k501d agoHangzhou SHINING3D Dental Technology Co., Ltd. — Denture Base Resin DT20 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 31, 2025device 510k501d agoOlympus Medical Systems Corp. — Disposable Grasping Forceps FG-52D/FG-54D (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 31, 2025device 510k501d agoBridge TO Life — Belzer UW® Cold Storage Solution (BTLBUW-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2025approval500d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

    Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Apr 1, 2025approval500d agoSTELARA (USTEKINUMAB) — FDA approvalustekinumab

    Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

    full page →ustekinumab →fda approvals ↗
    ›Apr 1, 2025approval500d agoADZENYS XR-ODT (AMPHETAMINE) — FDA approvalTraws Pharma, Inc.

    Sponsor: NEOS THERAPS. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Apr 1, 2025device 510k500d agoAdvalight Aps — AdvaTx (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k500d agoScientia Vascular, Inc. — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k500d agoGigaalaser Company , Ltd. — Medical Diode Laser Systems (THEIA808) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k500d agoTaiwan Medical Electronics Co., Ltd. — STOPWET iontophoresis apparatus (SW01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k500d agoIntuitive Surgical, Inc. — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k500d agoEssity Higiene Y Salud Mexico. S.A. DE C.V. — SABA Tampons (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k500d agoOrthoPediatrics Corp. — Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur (510k cleared)ORTHOPEDIATRICS CORP

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k500d agoGE Healthcare — MR Contour DL (510k cleared)HCA Healthcare, Inc.

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k500d agoCareglove Global Sdn. Bhd. — Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Apr 1, 2025device 510k500d agoEMA Aesthetics , Ltd. — Préime DermaFacial (MicroT) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025approval499d agoVANRAFIA (ATRASENTAN HYDROCHLORIDE) — FDA approvalatrasentan hydrochloride

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →atrasentan hydrochloride →fda approvals ↗
    ›Apr 2, 2025approval499d agoLIRAGLUTIDE — FDA approvalNovo Nordisk Inc

    Sponsor: NANJING KING FRIEND. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    $TRAW
    $CODX1.51000.00%
    $AZN157.24-0.79%
    $VANI1.6000+18.52%
    $NVS151.72-0.39%
    $NVS151.72-0.39%
    $MDCE0.00020.00%
    $SNN30.00+0.55%
    $PYPD4.7800-1.24%
    $AMRX17.73+0.42%
    $JNJ262.08+0.47%
    $TRAW
    $KIDS
    $NVS151.72-0.39%
    $ISRG401.270.00%
    $HCA411.74-0.69%