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10,001 catalysts · 3,126 8k filing · 2,091 grant · 1,128 approval · 1,000 device adverse event · 848 device 510k · 610 device pma

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2026-08-10: 0 catalysts2026-08-11: 97 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: 2 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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  • 8k filing3,126
  • grant2,091
  • approval1,128
  • device adverse event1,000
  • device 510k848
  • device pma610
earnings
583
  • device recall318
  • recall215
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jan 12, 2026

    50
    ›Jan 12, 2026device 510k212d agoMediclus Co., Ltd. — Any-Paste (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k212d agoTheotclab Healthcare B.V. — Dr. Yglo Skin Tag Remover (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device 510k212d agoSonomotion, Inc. — Break Wave (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 12, 2026device pma212d agoJohnson & Johnson Surgical Vision, Inc. — SENSAR 1-piece IOL, AAB00; SENSAR Soft Acrylic Posterior Chamber IOL, Models AR40e, AR40E, and AR40M; TECNIS 1-Piece I (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    ›Jan 12, 2026device pma212d agoFarapulse, Inc. — FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation C (PMA supplement)

    Supplement type: Panel Track. Product code: QZI. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jan 12, 2026device pma212d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS Foldable Acrylic IOL with OptiEdge, 13.0 mm, ZA9003 (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    ›Jan 12, 2026device pma212d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS Multi-focal 3-pc, ZMA00 (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    ›Jan 12, 2026device pma212d agoAbbott Vascular-Cardiac Therapies — Omnilink Elite Vascular Balloon-Expandable Stent System (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: NIO. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Jan 12, 2026device recall212d agoWaldemar Link GmbH & Co. KG (Mfg Site) device recall (Cls II)

    Endo-Model Replacement Plateau; Item Number: 15-0027/11; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing

    full page →fda device recalls ↗
    ›Jan 12, 2026device recall212d agoWaldemar Link GmbH & Co. KG (Mfg Site) device recall (Cls II)

    Endo-Model Replacement Plateau; Item Number: 15-8030/12; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing

    full page →fda device recalls ↗
    ›Jan 12, 2026device recall212d agoWaldemar Link GmbH & Co. KG (Mfg Site) device recall (Cls II)

    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing

    full page →fda device recalls ↗
    ›Jan 12, 2026device recall212d agoWaldemar Link GmbH & Co. KG (Mfg Site) device recall (Cls II)

    Endo-Model Replacement Plateau; Item Number: 15-8521/15; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing

    full page →fda device recalls ↗
    ›Jan 12, 2026device recall212d agoWaldemar Link GmbH & Co. KG (Mfg Site) device recall (Cls II)

    Endo-Model Replacement Plateau; Item Number: 15-0027/15; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing

    full page →fda device recalls ↗
    ›Jan 12, 2026device recall212d agoWaldemar Link GmbH & Co. KG (Mfg Site) device recall (Cls II)

    Endo-Model Replacement Plateau; Item Number: 15-2835/12; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing

    full page →fda device recalls ↗
    ›Jan 12, 2026device recall212d agoWaldemar Link GmbH & Co. KG (Mfg Site) device recall (Cls II)

    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing

    full page →fda device recalls ↗
    ›Jan 12, 2026device recall212d agoWaldemar Link GmbH & Co. KG (Mfg Site) device recall (Cls II)

    Endo-Model Replacement Plateau; Item Number: 15-2836/11; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing

    full page →fda device recalls ↗
    ›Jan 12, 2026device recall212d agoWaldemar Link GmbH & Co. KG (Mfg Site) device recall (Cls II)

    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing

    full page →fda device recalls ↗
    ›Jan 12, 2026device recall212d agoWaldemar Link GmbH & Co. KG (Mfg Site) device recall (Cls II)

    Endo-Model Replacement Plateau; Item Number: 15-8521/09; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing

    full page →fda device recalls ↗
    ›Jan 12, 2026device recall212d agoWaldemar Link GmbH & Co. KG (Mfg Site) device recall (Cls II)

    Endo-Model Replacement Plateau; Item Number: 15-8521/11; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing

    full page →fda device recalls ↗
    ›Jan 12, 2026device recall212d agoWaldemar Link GmbH & Co. KG (Mfg Site) device recall (Cls II)

    Endo-Model Replacement Plateau; Item Number: 15-0027/12; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing

    full page →fda device recalls ↗
    ›Jan 12, 2026device recall212d agoWaldemar Link GmbH & Co. KG (Mfg Site) device recall (Cls II)

    Endo-Model Replacement Plateau; Item Number: 15-0027/16; — Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. — Status: Ongoing

    full page →fda device recalls ↗
    ›Jan 12, 2026grant212d agoUNIVERSITY OF CALIFORNIA, SAN FRANCISCO — Exploring leaderless mRNA translation, a potential Achilles heel of mycobacteriaUniversity of California San Francisco

    AI grant. $75,052. PI: Sarah C Feid

    full page →nih reporter ↗
    ›Jan 12, 2026grant212d agoARKANSAS CHILDREN'S HOSPITAL RES INST — Growing Healthy Children and Families in Rural Arkansas

    GM grant. $132,469. PI: Martha Rojo

    full page →nih reporter ↗
    ›Jan 12, 2026grant212d agoUNIVERSITY OF COLORADO — Adolescent Friendship Networks: Effects on Immigrant Youth’s Psychosocial Health

    HD grant. $248,995. PI: Thoa Khuu

    full page →nih reporter ↗
    ›Jan 12, 2026grant212d agoNEW YORK UNIVERSITY SCHOOL OF MEDICINE — Mechanistic Insights Underlying LZTR1-Related SchwannomatosisNew York University

    NS grant. $579,610. PI: Pau Castel

    full page →nih reporter ↗
    ›Jan 12, 2026grant212d agoUNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR — STRONG HEART STUDY (SHS) - UNIVERSITY OF OKLAHOMA, FIELD CENTER (FC), TASK AR...

    HL grant. $469,049. PI: nagendra monangi

    full page →nih reporter ↗
    ›Jan 12, 2026grant212d agoMISSOURI BREAKS RESEARCH, INC. — STRONG HEART STUDY (SHS) - MISSOURI BREAKS INDUSTRIES RESEARCH, INC., FIELD C...

    HL grant. $154,846. PI: HELAINE E. RESNICK

    full page →nih reporter ↗
    ›Jan 12, 2026grant212d agoMEDSTAR HEALTH RESEARCH INSTITUTE — STRONG HEART STUDY (SHS) - MEDSTAR HEALTH RESEARCH INSTITUTE, INC., FIELD CEN...

    HL grant. $129,024. PI: DEDRA S BUCHWALD

    full page →nih reporter ↗
    ›Jan 12, 2026grant212d agoCOLORADO STATE UNIVERSITY — Transmission dynamics and fitness of reemerging St. Louis encephalitis virus ...

    AI grant. $87,244. PI: Jenny Ann Buczek

    full page →nih reporter ↗
    ›Jan 13, 2026approval211d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

    Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 13, 2026approval211d agoYESAFILI (AFLIBERCEPT-JBVF) — FDA approvalYESAFILI

    Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION

    full page →YESAFILI →fda approvals ↗
    ›Jan 13, 2026approval211d agoSODIUM BICARBONATE — FDA approvalSODIUM BICARBONATE

    Sponsor: AMNEAL. Form: SOLUTION. Route: INTRAVENOUS

    full page →SODIUM BICARBONATE →fda approvals ↗
    ›Jan 13, 2026approval211d agoISOVUE-250 (IOPAMIDOL) — FDA approval

    Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Jan 13, 2026approval211d agoISOVUE-370 (IOPAMIDOL) — FDA approval

    Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Jan 13, 2026approval211d agoBENAZEPRIL HYDROCHLORIDE — FDA approvalBENAZEPRIL HYDROCHLORIDE

    Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL

    full page →BENAZEPRIL HYDROCHLORIDE →fda approvals ↗
    ›Jan 13, 2026approval211d agoDEFLAZACORT — FDA approvalDEFLAZACORT

    Sponsor: ZYDUS LIFESCIENCES. Form: SUSPENSION. Route: ORAL

    full page →DEFLAZACORT →fda approvals ↗
    ›Jan 13, 2026device 510k211d agoMiach Orthopaedics, Inc. — BEAR® (Bridge-Enhanced ACL Restoration) Implant (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2026device 510k211d agoSpinal Resources, Inc. — Swedge™ Pedicle Screw Fixation System Bezier Rod (510k cleared)RGC RESOURCES INC

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

    full page →fda device 510k ↗
    ›Jan 13, 2026device 510k211d agoSpectrum Dynamics Medical, Ltd. — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2026device 510k211d agoDmp Dental Industry S.A. — Bright Cavity Liner (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2026device 510k211d agoStryker Endoscopy — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 13, 2026device 510k211d agoKossan International Sdn Bhd — Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Jan 13, 2026device pma211d agoMerz North America, Inc. — RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, Jawline indication (PMA supplement)Sustained Therapeutics Inc

    Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Jan 13, 2026device pma211d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗
    ›Jan 13, 2026device pma211d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗
    ›Jan 13, 2026device pma211d agoElement Science, Inc. — Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 13, 2026device pma211d agoABBOTT MEDICAL — Proclaim Dorsal Root Ganglion (DRG) Neurostimulator System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: PMP. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Jan 13, 2026device pma211d agoABBOTT MEDICAL — Eterna SCS and Proclaim SCS Systems (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Jan 13, 2026device pma211d agoMerz North America, Inc. — COAPTITE (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LNM. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗
    ›Jan 13, 2026device pma211d agoFarapulse, Inc. — FARAPULSE™ Pulsed Field Ablation System (FARAPULSE) (PMA supplement)

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

    full page →fda device pma ↗
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    $AMRX17.10-4.36%
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    $BSX51.32+1.70%
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