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calendar

25,352 catalysts · 5,402 approval · 5,000 device 510k · 4,728 grant · 3,431 8k filing · 2,000 device pma · 2,000 device recall

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  • approval5,402
  • device 510k5,000
  • grant4,728
  • 8k filing3,431
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Nov 11, 2024

    25
    ›Nov 15, 2024approval643d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

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

    full page →fda approvals ↗
    ›Nov 15, 2024approval643d agoSTELARA (USTEKINUMAB) — FDA approvalustekinumab

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

    full page →ustekinumab →fda approvals ↗
    ›Nov 15, 2024approval643d agoEPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

    Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION

    full page →EPYSQLI →fda approvals ↗
    ›Nov 15, 2024approval643d agoREVUFORJ (REVUMENIB CITRATE) — FDA approvalrevumenib citrate

    Sponsor: SYNDAX. Form: TABLET. Route: ORAL

    full page →revumenib citrate →fda approvals ↗
    ›Nov 15, 2024device 510k643d agoBoston Scientific Corporation — AdVance™ XP Male Sling System (720163-03) (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoHologic, Inc. — Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoDent4you AG — Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoCarlsmed, Inc. — aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM (510k cleared)CARLSMED, INC.

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoVuno, Inc. — VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoKoios Medical, Inc. — Koios DS (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoVascutek, Ltd. — Gelsoft™ Plus Vascular Prostheses (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoTianjin Huahong Technology Co., Ltd. — Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoMycardium AI Limited — 1CMR Pro (510k cleared)

    Product code: LLZ. Advisory committee: Radiology. Type: Abbreviated

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoCreagh Medical Ltd. Dba Surmodics, Inc. — 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoUltromics Limited — EchoGo Amyloidosis (1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoPhilips Ultrasound, LLC — The 5000 Compact Series Ultrasound Systems (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoVieworks Co., Ltd. — VIVIX-S 1751S (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoBlue Belt Technologies, Inc. — CORIOGRAPH Pre-Op Planning and Modeling Services (510k cleared)BETA Technologies, Inc.

    Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoShenzhen Vitavitro Biotech Co., Ltd. — VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) (510k cleared)Shenzhen MagicRNA Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoInfinitum Eta, Ltd. — NUVENTUS NV.C™ Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoB-One Ortho, Corp. — b-ONE® Total Hip System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoTHINK Surgical, Inc. — TMINI Miniature Robotic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoSurgical Instrument Service and Savings Inc.(Dba Medline Ren — Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoSiemens Medical Solutions USA, Inc. — ACUSON Redwood Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 15, 2024device 510k643d agoLivsmed, Inc. — ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator (510k cleared)

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

    full page →fda device 510k ↗

    Week of Nov 18, 2024

    25
    ›Nov 18, 2024device 510k640d agoMindset Medical, Inc. — Informed Vital Core Application (IVC App) (510k cleared)Outset Medical, Inc.

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k
    ← prev
    page 54 of 508
    next →
    640d ago
    Sorin Group Italia S.R.L. — MICRO Arterial Filters (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k640d agoZhejiang Innuovo Rehabilitation Devices Co.,Ltd — Power Wheelchair (W5538) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k640d agoOrthocon, Inc. — Montage-XT Settable Bone Putty (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k640d agoZhejiang Zhonglei Medical Technology Co. , Ltd. — Power wheelchair (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k640d agoTrice Medical, Inc. — Tenex 2nd Generation System (510k cleared)Tenon Medical, Inc.

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k640d agoDeepHealth, Inc. — Saige-Dx (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k640d agoXiamen Weiyou Intelligent Technology Co., Ltd. — Air Pressure Therapy System (VU-IPC04B) (510k cleared)

    Product code: IRP. Advisory committee: Physical Medicine. Type: Special

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k640d agoHebei Keylaser Sci-Tech Co.,Ltd — Diode laser Treatment System (K18) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k640d agoEnlight Medical Technologies (Shenzhen) Co., Ltd. — Synxess Neurovascular Guidewire (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k640d agoIntuitive Surgical, Inc. — da Vinci SP Instruments (SP1098) (510k cleared)INTUITIVE SURGICAL INC

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

    full page →fda device 510k ↗
    ›Nov 18, 2024device 510k640d agoPhilips Healthcare (Suzhou) Co., Ltd. — CT Collaboration Live (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024approval639d agoQSYMIA (PHENTERMINE HYDROCHLORIDE) — FDA approval(phentermine hydrochloride + topiramate) ER

    Sponsor: VIVUS LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →(phentermine hydrochloride + topiramate) ER →fda approvals ↗
    ›Nov 19, 2024approval639d agoPAXLOVID (COPACKAGED) (NIRMATRELVIR) — FDA approvalPAXLOVID (COPACKAGED)

    Sponsor: PFIZER. Form: TABLET. Route: ORAL

    full page →PAXLOVID (COPACKAGED) →fda approvals ↗
    ›Nov 19, 2024device 510k639d agoCerrozone, LLC — CerroZone Mini (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k639d agoNova Biomedical Corporation — Nova Allegro UACR Assay, Nova Allegro Analyzer (510k cleared)

    Product code: CGX. Advisory committee: Clinical Chemistry. Type: Dual Track

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k639d agoMaxx Orthopedics, Inc. — Freedom® Medial Congruent Liner (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k639d agoPolarean, Inc. — XENOVIEW 3.0T Chest Coil (510k cleared)Polaris Inc.

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k639d agoRiverpoint Medical — Iconix Knotless Anchor (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k639d agoDongguanshi Yiyingmei Technology Co., Ltd. — Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k639d agoEieling Technology (Shenzhen) Limited — Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k639d agoBraxx Biotech Co., Ltd. — “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k639d agoTaidoc Technology Corporation — XPER Technology PREMIUM Pro Blood Glucose Monitoring System (510k cleared)

    Product code: PZI. Advisory committee: Clinical Chemistry. Type: Dual Track

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k639d agoRhein Laser Technologies Co., Ltd. — Medical Thulium Fiber Laser Systems (UroFiber 60Q) (510k cleared)

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

    full page →fda device 510k ↗
    ›Nov 19, 2024device 510k639d agoMiRus, LLC — EUROPA™ Posterior Cervical Fusion System (510k cleared)

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

    full page →fda device 510k ↗
    $JNJ273.41+0.85%
    $CARL
    $BSX52.01+3.05%
    $SNDX20.77+4.29%
    $OM4.5200-1.09%
    $BETA16.10+2.09%
    $PFE28.25+3.69%
    $PII66.00-2.38%
    $ISRG397.72+1.67%
    $TNON0.2832-3.11%