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calendar

21,452 catalysts · 4,728 grant · 3,882 device 510k · 3,189 8k filing · 3,057 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 82 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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  • grant4,728
  • device 510k3,882
  • 8k filing3,189
  • approval3,057
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall931
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Feb 17, 2025

    46
    ›Feb 21, 2025approval538d agoSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 21, 2025approval538d agoSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: RUBICON RESEARCH. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: TEVA PHARMS USA. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

    Sponsor: RHODES PHARMS. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

    Sponsor: ALKEM LABS LTD. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›Feb 21, 2025approval538d agoSUBLOCADE (BUPRENORPHINE) — FDA approvalbuprenorphine LA

    Sponsor: INDIVIOR. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS

    full page →buprenorphine LA →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

    Sponsor: RHODES PHARMS. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›Feb 21, 2025approval538d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: INDIVIOR. Form: FILM. Route: BUCCAL, SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

    Sponsor: BARR. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›Feb 21, 2025approval538d agoZUBSOLV (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalEdenbridge Pharmaceuticals LLC

    Sponsor: EDENBRIDGE PHARMS. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: LANNETT CO INC. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: AMNEAL PHARMS. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›Feb 21, 2025approval538d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval538d agoANASTROZOLE — FDA approvalANASTROZOLE

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →ANASTROZOLE →fda approvals ↗
    ›Feb 21, 2025device 510k538d agoOrthopediatrics Canada Ulc Dba Pega Medical — Fassier-Duval Telescoping IM System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoTaiwan Dental Materials Co., Ltd. — TEMP MASTER, PMMA-based dental resin (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoLyma Life , Ltd. — LYMA Laser PRO (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoSpinal Elements, Inc. — Primus Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoExtremity Medical, LLC — Extremity Medical External Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoScandiags AG — ScanDiags Ortho L-Spine MR-Q (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoChurch & Dwight Co., Inc. — Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) (510k cleared)CHURCH & DWIGHT CO INC /DE/

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoIntradin (Shanghai) Machinery Co., Ltd. — Powered Mobility Scooter (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoVATECH Co., Ltd. — Green X 12 SE (PHT-40CHS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoShenzhen Dazhou Medical Technology Co., Ltd. — Synthetic Bone Graft Particulate (510k cleared)Guangzhou Dazhou Biomedical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoInstitut Straumann AG — Custom Abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoAikenist Technologies Pvt, Ltd. — QuickRad (510k cleared)Pandorum Technologies Pvt Ltd

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoMedicom Asia-Pacific Holdings Ltd. Taiwan Branch. — Medicom Sterilization Pouch and Reel (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoShenzhen Urion Technology Co., Ltd. — Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoVita Zahnfabrik H.Rauter GmbH & Co. — VITA YZ Multi Translucent (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoRti Surgical, Inc. — Moldable Bone Void Filler and Moldable Bone Void Filler + CCC (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoCepheid — Xpert® FII & FV (510k cleared)

    Product code: NPR. Advisory committee: Hematology. Type: Special

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoMaterialise NV — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery (510k cleared)MATERIALISE NV

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoShenzhen TPH Technology Co., Ltd. — Wearable breast pump (model W8) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoShanghai Jianzhong Medical Packaging Co., Ltd. — Sterilization Pouches and Reels (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoProprio, Inc. — Paradigm System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 21, 2025device 510k538d agoSonio — Sonio Suspect (510k cleared)

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

    full page →fda device 510k ↗

    Week of Feb 24, 2025

    4
    ›Feb 24, 2025approval535d agoSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 24, 2025approval
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    535d ago
    POSACONAZOLE — FDA approvalPOSACONAZOLE

    Sponsor: MSN. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →POSACONAZOLE →fda approvals ↗
    ›Feb 24, 2025approval535d agoMIUDELLA (COPPER) — FDA approval

    Sponsor: SEBELA WOMENS HLTH. Form: SYSTEM. Route: INTRAUTERINE

    full page →fda approvals ↗
    ›Feb 24, 2025device 510k535d agoAnqing Clean Dental Instrument Technology Co., Ltd. — Sterilization Package/Reel (510k cleared)

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

    full page →fda device 510k ↗
    $IGC0.2670+0.41%
    $AMRX17.52+2.43%
    $INDV38.73+0.78%
    $INDV38.73+0.78%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $FRTRY
    $CHD101.70-1.05%
    $MTLS6.5600-1.06%
    $FRTRY