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21,504 catalysts · 4,728 grant · 3,890 device 510k · 3,223 8k filing · 3,063 approval · 2,000 device pma · 2,000 device recall

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  • grant4,728
  • device 510k3,890
  • 8k filing3,223
  • approval3,063
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall935
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Mar 31, 2025

    49
    ›Apr 2, 2025device 510k499d agoBiocircuit Technologies, Inc. — Nerve Wrap (07-DW-001-TAB) (510k cleared)BWX Technologies, Inc.

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k499d agoGynesonics, Inc. — Sonata Transcervical Fibroid Ablation System 2.2 (510k cleared)

    Product code: KNF. Advisory committee: Obstetrics/Gynecology. Type: Special

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k499d agoIcu Medical, Inc. — LifeShield Infusion Safety Software Suite (510k cleared)ICU MEDICAL INC/DE

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k499d agoNvision Biomedical Technologies, Inc. — SnapHammer Hammertoe Correction System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k499d agoAsahi Intecc Co., Ltd. — SION blue PLUS (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 2, 2025device 510k499d agoShenzhen TPH Technology Co., Ltd. — eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060; (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

    Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Special

    full page →fda device 510k ↗
    ›Apr 3, 2025approval498d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Apr 3, 2025approval498d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: WES PHARMA INC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Apr 3, 2025approval498d agoUPLIZNA (INEBILIZUMAB-CDON) — FDA approvalHorizon Therapeutics USA Inc

    Sponsor: VIELA BIO. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Apr 3, 2025device 510k498d agoSiemens Healthcare GmbH — syngo Dynamics (Version VA41D) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k498d agoFresenius Medical Care Renal Therapies Group, LLC — stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k498d agoCarbon (Shenzhen) Medical Device Co., Ltd. — Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k498d agoShina Med Corporation — SureFine Pen Needle (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k498d agoBeaver-Visitec International, Inc. — Leos Laser and Endoscopy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k498d agoOSSIO , Ltd. — OSSIOfiber® Suture Anchor 2.5-3.5 mm (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k498d agoXsto Co., Ltd. — Powered wheelchair (mobility robot) (M4, M4U) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k498d agoStaclear, Inc. — StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k498d agoSpine Wave, Inc. — Salvo® Robotic Navigation Instruments (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 3, 2025device 510k498d agoMasimo Corporation — Masimo W1 (510k cleared)MASIMO CORP

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

    full page →fda device 510k ↗
    ›Apr 4, 2025approval497d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

    Sponsor: CUBIST PHARMS LLC. Form: TABLET. Route: ORAL

    full page →tedizolid phosphate →fda approvals ↗
    ›Apr 4, 2025approval497d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

    Sponsor: CUBIST PHARMS LLC. Form: POWDER. Route: INTRAVENOUS

    full page →tedizolid phosphate →fda approvals ↗
    ›Apr 4, 2025approval497d agoAMBRISENTAN — FDA approvalAMBRISENTAN

    Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL

    full page →AMBRISENTAN →fda approvals ↗
    ›Apr 4, 2025approval497d agoAMBRISENTAN — FDA approvalAMBRISENTAN

    Sponsor: SIGMAPHARM LABS LLC. Form: TABLET. Route: ORAL

    full page →AMBRISENTAN →fda approvals ↗
    ›Apr 4, 2025approval497d agoAMBRISENTAN — FDA approvalSigmapharm Laboratories LLC

    Sponsor: SUN PHARM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 4, 2025approval497d agoAMBRISENTAN — FDA approvalAMBRISENTAN

    Sponsor: APOTEX. Form: TABLET. Route: ORAL

    full page →AMBRISENTAN →fda approvals ↗
    ›Apr 4, 2025device 510k497d agoBiotronik, Inc. — Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoNingbo Dechang Electrical Machinery Made Co.,Ltd — LED Light Therapy Mask (RT01) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoPhilips Medical Systems Nederland B.V. — Philips VSC-MEDlib (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoABBOTT MEDICAL — JETi Hydrodynamic Thrombectomy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoDeski — HeartFocus (V.1.1.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoTerumo Europe N.V. — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoHighridge Medical, LLC — Virage® OCT Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoWuhan Pioon Technology Co., Ltd. — Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoTurbett Surgical — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoHangzhou AllTest Biotech Co., Ltd. — AllTest Viral Transport Medium (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoPrapela, Inc. — Prapela SVS hospital bassinet pad (model P01) (510k cleared)

    Product code: QVY. Advisory committee: General Hospital. Type: Direct

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoApex BioTechnology Corp. — UASure II Blood Uric Acid Monitoring System (510k cleared)PDS Biotechnology Corp

    Product code: PTC. Advisory committee: Clinical Chemistry. Type: Traditional

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoDraegerwerk AG & CO Kgaa — VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoRaySearch Laboratories AB (PUBL) — RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoHangzhou AllTest Biotech Co., Ltd. — AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup (510k cleared)Hangzhou DAC Biotech Co Ltd

    Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoWhoop., Inc. — WHOOP ECG (electrocardiogram) Feature (1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoSpectrum Spine, Inc. — Spectrum Spine Lumbar Cage System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoFoqus Technologies, Inc. — DeepFoqus (DeepFoqus-Accelerate) (510k cleared)FOXO TECHNOLOGIES INC.

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoDegen Medical — DeGen Medical Patient Specific Implant (PSI) System (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoFresenius Medical Care Renal Therapies Group, LLC — Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) (510k cleared)Fresenius Medical Care AG

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d ago3Shape TRIOS A/S — TRIOS Ready Tip (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoOculogica, Inc. — EyeBOX EBX-4.1 (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoQfr Solutions BV — QFR (3.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Apr 4, 2025device 510k497d agoSeigla Medical, Inc. — LiquID .051 LP Guide Catheter Extension (510k cleared)

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

    full page →fda device 510k ↗

    Week of Apr 7, 2025

    1
    ›Apr 7, 2025approval494d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

    full page →Spexotras →fda approvals ↗
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    $BWXT
    $IGC0.2670+0.41%
    $FRTRY
    $FMS23.72-0.63%
    $FOXO
    $NVS152.32-1.48%
    $PDSB0.2420-5.76%
    $ICUI179.34-1.50%
    $FMS23.72-0.63%
    $MASI