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calendar

21,153 catalysts · 4,728 grant · 3,704 device 510k · 3,126 8k filing · 3,015 approval · 2,000 device pma · 2,000 device recall

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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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type
  • grant4,728
  • device 510k3,704
  • 8k filing3,126
  • approval3,015
  • device pma2,000
  • device recall2,000
  • device adverse event1,000
  • recall915
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Mar 3, 2025

    31
    ›Mar 6, 2025device 510k524d agoXtreem Pulse, LLC — PureLift GLOW (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k524d agoZimmer, Inc. — Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k524d agoMedacta International S.A. — Versacem Acetabular Shell and Double Mobility HC Liners (510k cleared)Stemedica International S.A.

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k524d agoBecton, Dickinson and Company — BD Phoenix™ Automated Microbiology System (510k cleared)BECTON DICKINSON & CO

    Product code: LON. Advisory committee: Microbiology. Type: Special

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k524d agoMiach Orthopaedics, Inc. — BEAR® (Bridge-Enhanced ACL Restoration) Implant (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 6, 2025device 510k524d agoPhilips Medical Systems Nederland B.V. — Philips IntelliSite Pathology Solution 5.1 (510k cleared)

    Product code: PSY. Advisory committee: Pathology. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 7, 2025approval523d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Mar 7, 2025approval523d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

    Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

    full page →dabrafenib mesylate ODT →fda approvals ↗
    ›Mar 7, 2025approval523d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Mar 7, 2025approval523d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

    Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

    full page →dabrafenib mesylate ODT →fda approvals ↗
    ›Mar 7, 2025approval523d agoGLATOPA (GLATIRAMER ACETATE) — FDA approvalGLATIRAMER ACETATE

    Sponsor: SANDOZ. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →GLATIRAMER ACETATE →fda approvals ↗
    ›Mar 7, 2025approval523d agoGLATOPA (GLATIRAMER ACETATE) — FDA approvalGLATIRAMER ACETATE

    Sponsor: SANDOZ. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →GLATIRAMER ACETATE →fda approvals ↗
    ›Mar 7, 2025approval523d agoOMLYCLO (OMALIZUMAB-IGEC) — FDA approvalomalizumab biosimilar

    Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INJECTION

    full page →omalizumab biosimilar →fda approvals ↗
    ›Mar 7, 2025approval523d agoSYNJARDY XR (EMPAGLIFLOZIN) — FDA approval(empagliflozin + metformin hydrochloride ER)

    Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →(empagliflozin + metformin hydrochloride ER) →fda approvals ↗
    ›Mar 7, 2025approval523d agoSYNJARDY (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

    Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

    full page →SYNJARDY →fda approvals ↗
    ›Mar 7, 2025device 510k523d agoEpiwatch, Inc. — EpiWatch Monitoring System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k523d agoBatec Mobility, S.L. — Handbike Batec Electric (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k523d agoFort Defiance Industries, LLC — FRONT-LINE Field Sterilizer (FL135) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k523d agoShenzhen Rogin Medical Co., Ltd. — Apex Locator (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k523d agoIntradin (Shanghai) Machinery Co., Ltd. — Portable Wheelchair (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k523d agoShanghai Longmann Tech Co., Ltd. — CuffTrek (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k523d agoGeistlich Pharma AG — Geistlich Bio-Flow® (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k523d agoDaeju Meditech Engineering Co., Ltd. — NOABLE LASER (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k523d agoAtmos Medizintechnik GmbH & Co. KG — ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k523d agoCleerly, Inc. — Cleerly LABS (v2.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k523d agoSpineart SA — SPINEART Navigation Instrument System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k523d agoEcential Robotics — Op.n(TM) Navigation (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k523d agoLelo, Inc. — Lelo Hex Lubricated Natural Rubber Latex Condom (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k523d agoMedartis AG — APTUS Hand System; APTUS Elbow Dorsal Olecranon (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k523d agoShanghai SeeGen Photoelectric Technology Co., Ltd. — Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 7, 2025device 510k523d agoOrthoPediatrics Corp. — Orthex External Fixation System (510k cleared)ORTHOPEDIATRICS CORP

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

    full page →fda device 510k ↗

    Week of Mar 10, 2025

    19
    ›Mar 10, 2025approval520d agoTROKENDI XR (TOPIRAMATE) — FDA approvalSUPERNUS PHARMACEUTICALS, INC.

    Sponsor: SUPERNUS PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Mar 10, 2025approval
    ← prev
    page 5 of 424
    next →
    520d ago
    PRIMAQUINE (PRIMAQUINE PHOSPHATE) — FDA approvalprimaquine phosphate

    Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

    full page →primaquine phosphate →fda approvals ↗
    ›Mar 10, 2025approval520d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Mar 10, 2025approval520d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Mar 10, 2025approval520d agoXPOVIO (SELINEXOR) — FDA approvalselinexor

    Sponsor: KARYOPHARM THERAPS. Form: TABLET. Route: ORAL

    full page →selinexor →fda approvals ↗
    ›Mar 10, 2025device 510k520d agoImplantcast GmbH — AGILON® XO Shoulder Replacement System (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2025device 510k520d agoIntuitive Surgical, Inc. — da Vinci SP SureForm 45 Staplers and Reloads (SP1098) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Mar 10, 2025device 510k520d agoMedtronic Neurosurgery — Duet External Drainage and Monitoring System (EDMS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2025device 510k520d agoSurgical Instrument Service and Savings, Inc. — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2025device 510k520d agoExactech, Inc. — Alteon® HA Femoral Stems (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 10, 2025device 510k520d agoVaporox, Inc. — Wound Treatment System (VHT-200) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2025approval519d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

    Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

    full page →triptorelin pamoate ER →fda approvals ↗
    ›Mar 11, 2025approval519d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

    Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

    full page →triptorelin pamoate ER →fda approvals ↗
    ›Mar 11, 2025approval519d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

    Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

    full page →triptorelin pamoate ER →fda approvals ↗
    ›Mar 11, 2025device 510k519d agoIconocare Health — 8mm Monopolar Curved Scissors (470179) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2025device 510k519d agoStryker Instruments — iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2025device 510k519d agoDeka Research & Development Corp. — RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (510k cleared)UNITED THERAPEUTICS Corp

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

    full page →fda device 510k ↗
    ›Mar 11, 2025device 510k519d agoArthrex, Inc. — Arthrex TightRope Soft Button, RT (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 11, 2025device 510k519d agoDisa Medinotec — OutFlo Aortic Valve Dilatation Balloon Catheter (510k cleared)

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

    full page →fda device 510k ↗
    $BDX181.41+0.99%
    $KIDS
    $NVS154.61-1.39%
    $NVS154.61-1.39%
    $NVS154.61-1.39%
    $NVS154.61-1.39%
    $SUPN46.88-0.40%
    $ISRG401.23+2.00%
    $KPTI
    $UTHR515.50-2.67%