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19,656 catalysts · 4,728 grant · 3,126 8k filing · 2,768 device 510k · 2,721 approval · 2,000 device recall · 1,955 device pma

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 19 catalysts2026-08-13: 19 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
  • 8k filing3,126
  • device 510k2,768
  • approval2,721
  • device recall2,000
  • device pma1,955
device adverse event
1,000
  • recall693
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jun 9, 2025

    50
    ›Jun 11, 2025device 510k427d agoMedtronic, Ireland — Liberant Thrombectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k427d agoWilliam Cook Europe Aps — Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k427d agoGI Windows, Inc. — Self-Forming Magnet (Flexagon) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k427d agoAmbu A/S — Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k427d agoCarl Zeiss Meditec Cataract Technology, Inc. — MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) (510k cleared)

    Product code: HQC. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Jun 11, 2025device 510k427d agoEnpuno Co., Ltd. — Injectable Root Canal Bioceramic Sealer (nRoot SP) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025approval426d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›Jun 12, 2025approval426d agoVOQUEZNA TRIPLE PAK (AMOXICILLIN) — FDA approvalamoxicillin + clarithromycin + vonoprazan

    Sponsor: PHATHOM. Form: CAPSULE, TABLET, TABLET. Route: ORAL

    full page →amoxicillin + clarithromycin + vonoprazan →fda approvals ↗
    ›Jun 12, 2025approval426d agoVOQUEZNA DUAL PAK (AMOXICILLIN) — FDA approvalamoxicillin + vonoprazan fumarate

    Sponsor: PHATHOM. Form: CAPSULE, TABLET. Route: ORAL

    full page →amoxicillin + vonoprazan fumarate →fda approvals ↗
    ›Jun 12, 2025approval426d agoDELSTRIGO (DORAVIRINE) — FDA approval(doravirine + lamivudine + tenofovir disoproxil fumarate)

    Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL

    full page →(doravirine + lamivudine + tenofovir disoproxil fumarate) →fda approvals ↗
    ›Jun 12, 2025device pma426d agoBiotronik, Inc. — Sentus QP Pacing Leads (PMA supplement)

    Supplement type: Normal 180 Day Track No User Fee. Product code: NKE. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 12, 2025device pma426d agoMedtronic, Inc. — Harmony Transcatheter Pulmonary Valve System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 12, 2025device pma426d agoBiotronik, Inc. — Sentus QP Pacing Leads (PMA supplement)

    Supplement type: Normal 180 Day Track No User Fee. Product code: MRM. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jun 12, 2025device pma426d 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 ↗
    ›Jun 12, 2025device pma426d agoMedtronic Vascular — Endurant Stent Graft System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 12, 2025device pma426d agoRayner Intraocular Lenses , Ltd. — C-flex lntraocular Lens; C-flex Aspheric lntraocular Lens; 6.0 mm Aspheric lntraocular Lens; RayOne Aspheric; RayOne Sph (PMA supplement)

    Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Jun 12, 2025device pma426d agoMedtronic Vascular — Valiant Thoracic Stent Graft with the Captivia Delivery System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 12, 2025device 510k426d agoHt Medical D.B.A. Xenix Medical — RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k426d agoNovapproach Spine, LLC — OneLIF™ Interbody Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k426d agoBiomérieux — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (510k cleared)Bristol-Myers Squibb Co

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k426d agoDavol, Inc. — Bard® Mesh; Bard® Mesh Pre-Shaped (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k426d agoZhengzhou PZ Laser Slim Technology Co., Ltd. — Fractional CO2 Laser Machine (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k426d agoSmith & Nephew, Inc. — TRIGEN Stable Lock Nut & Washer (510k cleared)SMITH & NEPHEW PLC

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k426d agoGe Medical Systems Israel — Aurora (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k426d agoEl.En S.P.A. — Deka Bluebeam (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k426d agoId-Fish Technology, Inc. — iDart Lyme IgM ImmunoBlot Kit (510k cleared)Fort Technology Inc

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k426d agoBiocomposites, Ltd. — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k426d agoBeijing Sano Laser S&T Development Co.,Ltd — Q-Switched Nd:YAG Laser (SHE-LSP101-1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k426d agoJeil Medical Corporation — FIX-L PEEK PLIF and T-PLIF System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k426d agoGm Dos Reis Industria E Comercio — GMReis Fibula Nail System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k426d agoLg Electronics.Inc — Medical Monitor (32HS710S) (510k cleared)ARROW ELECTRONICS, INC.

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k426d agoPearl, Inc. — Second Opinion® CS (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k426d agoMedtronic Sofamor Danek, Inc. — Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k426d agoDmax Co., Ltd. — Multi M Series (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k426d agoOlympus Medical Systems Corporation — Disposable Cytology Brush BC-202D/203D Series (510k cleared)

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k426d agoThermo Fisher Scientific (Oxoid Ltd.) — Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Jun 12, 2025device 510k426d agoFiralis SA — APO-Easy Genotyping kit (510k cleared)Dawn Sea Therapeutics

    Product code: SFC. Advisory committee: Immunology. Type: Direct

    full page →fda device 510k ↗
    ›Jun 13, 2025approval425d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jun 13, 2025approval425d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jun 13, 2025approval425d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

    Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL

    full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗
    ›Jun 13, 2025approval425d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

    Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL

    full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗
    ›Jun 13, 2025approval425d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

    Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL

    full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗
    ›Jun 13, 2025approval425d agoSTEQEYMA (USTEKINUMAB-STBA) — FDA approvalSTEQEYMA

    Sponsor: CELLTRION, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →STEQEYMA →fda approvals ↗
    ›Jun 13, 2025device pma425d agoMedtronic, Inc. — Aurora EV ICD DVEA3E4 (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 13, 2025device pma425d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 13, 2025device pma425d agoMedtronic, Inc. — PulseSelect™ Pulsed Field Ablation (PFA) system (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 13, 2025device pma425d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 13, 2025device pma425d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4, Brava CRT-D DTBC1D1; Bra (PMA supplement)

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

    full page →fda device pma ↗
    ›Jun 13, 2025device pma425d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG ADDRS1, VEDR01; Adapta, Versa, Sensia IPG ADDR03, ADDRL1, ADSR03, SESR01; Adapta, Versa, Sensi (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Jun 13, 2025device pma425d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (PMA supplement)

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

    full page →fda device pma ↗
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    $PHAT8.5100-0.70%
    $MRK130.42-0.38%
    $FRTT
    $PHAT8.5100-0.70%
    $SNN30.01-0.23%
    $MDT90.68+1.42%
    $MDT90.68+1.42%
    $TMO447.81+1.31%
    $ARW226.78+1.76%
    $MDT90.68+1.42%
    $MDT90.68+1.42%