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12,085 catalysts · 3,404 8k filing · 2,283 grant · 1,778 approval · 1,169 device 510k · 1,000 device adverse event · 849 device pma

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  • 8k filing3,404
  • grant2,283
  • approval1,778
  • device 510k1,169
  • device adverse event1,000
  • device pma849
device recall
655
  • earnings584
  • recall282
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Dec 22, 2025

    50
    ›Dec 23, 2025approval239d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

    full page →METHADONE HYDROCHLORIDE →fda approvals ↗
    ›Dec 23, 2025approval239d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: SANKALP LIFECARE. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Dec 23, 2025approval239d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Dec 23, 2025approval239d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Dec 23, 2025approval239d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

    Sponsor: ABBVIE INC. Form: VIAL

    full page →adalimumab →fda approvals ↗
    ›Dec 23, 2025approval239d agoGLYCOPYRROLATE — FDA approvalGLYCOPYRROLATE

    Sponsor: BIONPHARMA. Form: SOLUTION. Route: ORAL

    full page →GLYCOPYRROLATE →fda approvals ↗
    ›Dec 23, 2025device 510k239d agoShenzhen Siken 3D Technology Development Co., Ltd. — Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoNakanishi, Inc. — VarioSurg 4 (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoUpdoc, Inc. — UpDoc (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoDiasorin Molecular, LLC — LIAISON NES FLU A/B, RSV & COVID-19 (510k cleared)

    Product code: QOF. Advisory committee: Microbiology. Type: Dual Track

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoHealgen Scientific,, LLC — Healgen® URS Test Strips (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoHycor Biomedical — NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) (510k cleared)Dawn Sea Therapeutics

    Product code: DHB. Advisory committee: Immunology. Type: Traditional

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoCylite Pty. , Ltd. — UNITY DX (UDX) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoPhilips Consumer Lifestyle B.V. — Philips Lumea IPL (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoSignature Orthopaedics Pty, Ltd. — Active-V Total Knee System; World Total Knee System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoHong Qiangxing (Shenzhen) Electronics Limited — TENS&EMS (HZ9151B, HZ9151C, HZ9151D) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoOrangecad Med GmbH — OrangeCAD Med Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoDynapulse Medical — VEINOPLUS Back (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoAura Medical, LLC — Aura Glide (FC40) (510k cleared)QOL Medical LLC

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoBruno Vision Care, LLC — Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoDongguan Yijiaming Technology Co., Ltd. — LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoGe Medical Systems, LLC — AIR Recon DL (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoLinhejiacheng (Shenzhen) E-Commerce Co., Ltd. — Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoMedimaging Integrated Solution, Inc (Miis) — MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoGuangdong Prestige Technology Co., Ltd. — Electric Scooter (S202572J, S2060, M2089, S2050) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoParagon Implant Mfg., LLC — NizPlant Dental Implant System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoHai Solutions — QIKCAP System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoShenzhen Safesecure Medical Infection Control Tech Co. , Ltd. — SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) (510k cleared)Kortuc Japan LLC

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoEdan Instruments, Inc. — Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) (510k cleared)VEECO INSTRUMENTS INC

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoHealgen Scientific,, LLC — Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoDiaSorin, Inc. — LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) (510k cleared)Dawn Sea Therapeutics

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoParagon Implant Mfg., LLC — GEN5™ and GEN5+™ 3.3mmD Dental Implants (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoMedentika GmbH — Custom Abutments AS (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoTherapanacea Sas — ART-Plan+ (v3.1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoSim&Cure — Sim&Size (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device 510k239d agoOsteoremedies, LLC — OsteoRemedies Hip Spacer System (510k cleared)

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

    full page →fda device 510k ↗
    ›Dec 23, 2025device pma239d agoABBOTT MEDICAL — Infinity™ Deep Brain Stimulation (DBS) System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30

    full page →fda device pma ↗
    ›Dec 23, 2025device pma239d agoMesoblast — SYNOJOYNT™ (PMA supplement)MESOBLAST LTD

    Supplement type: 30-Day Notice. Product code: MOZ. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Dec 23, 2025device pma239d agoABBOTT MEDICAL — Proclaim™ Spinal Cord Stimulation (SCS) System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30

    full page →fda device pma ↗
    ›Dec 23, 2025device pma239d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 23, 2025device pma239d agoQ-Med AB — Restylane® Lyft with Lidocaine (PMA supplement)Sustained Therapeutics Inc

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

    full page →fda device pma ↗
    ›Dec 23, 2025device pma239d agoRayner Intraocular Lenses , Ltd. — C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 23, 2025device pma239d agoBioventus, LLC — DUROLANE (PMA supplement)Bioventus Inc.

    Supplement type: 30-Day Notice. Product code: MOZ. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Dec 23, 2025device pma239d agoCooperVision, Inc. — MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 23, 2025device pma239d agoSt Jude Medical — TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (PMA supplement)

    Supplement type: Real-Time Process. Product code: OAE. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 23, 2025device pma239d agoABBOTT MEDICAL — Amplatzer™ Amulet™ Left Atrial Appendage Occluder (PMA supplement)

    Supplement type: Real-Time Process. Product code: NGV. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 23, 2025device pma239d agoMedtronic Neuromodulation — InterStim™ Therapy System, Verify™ Evaluation System (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 23, 2025device pma239d agoVantive US Healthcare, LLC — Gambro Prismaflex TPE 2000 Set (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 23, 2025device pma239d agoBiosense Webster, Inc. — TRUPULSE™ Generator (PMA supplement)

    Supplement type: Real-Time Process. Product code: QZI. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 23, 2025device pma239d agoBiosense Webster, Inc. — nGEN™ Pump (PMA supplement)

    Supplement type: Real-Time Process. Product code: LPB. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
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    $BVS8.6700+1.40%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $ABBV258.92+3.43%
    $MESO16.67-2.06%
    $VECO59.42+2.95%
    $IGC0.2670+0.41%