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8,689 catalysts · 3,086 8k filing · 1,702 grant · 1,000 device adverse event · 795 approval · 621 device 510k · 583 earnings

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  • 8k filing3,086
  • grant1,702
  • device adverse event1,000
  • approval795
  • device 510k621
  • earnings583
device pma
467
  • device recall191
  • phase 2 completion172
  • recall162
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Feb 9, 2026

    50
    ›Feb 11, 2026grant182d agoINDIANA UNIVERSITY INDIANAPOLIS — World Parkinson Congress 2026 Support

    NS grant. $25,000. PI: Maria de Lourdes Gamez Tansey

    full page →nih reporter ↗
    ›Feb 12, 2026approval181d agoCLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

    Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

    full page →CLEOCIN →fda approvals ↗
    ›Feb 12, 2026approval181d agoCLEOCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) — FDA approvalclindamycin hydrochloride

    Sponsor: PFIZER. Form: CAPSULE. Route: ORAL

    full page →clindamycin hydrochloride →fda approvals ↗
    ›Feb 12, 2026approval181d agoCLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

    Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

    full page →CLEOCIN →fda approvals ↗
    ›Feb 12, 2026approval181d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

    full page →tramadol hydrochloride ER →fda approvals ↗
    ›Feb 12, 2026approval181d agoENJUVIA (ESTROGENS, CONJUGATED SYNTHETIC B) — FDA approvalENJUVIA

    Sponsor: ASPEN. Form: TABLET. Route: ORAL

    full page →ENJUVIA →fda approvals ↗
    ›Feb 12, 2026approval181d agoFLUOROMETHOLONE — FDA approvalDifGen Pharmaceuticals LLC

    Sponsor: DIFGEN PHARMS. Form: SUSPENSION/DROPS. Route: OPHTHALMIC

    full page →fda approvals ↗
    ›Feb 12, 2026approval181d agoLEQVIO (INCLISIRAN SODIUM) — FDA approvalinclisiran

    Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →inclisiran →fda approvals ↗
    ›Feb 12, 2026approval181d agoLEQVIO (INCLISIRAN SODIUM) — FDA approvalinclisiran

    Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →inclisiran →fda approvals ↗
    ›Feb 12, 2026approval181d agoPROMETRIUM (PROGESTERONE) — FDA approvalIBSA Institut Biochimique SA

    Sponsor: ACERTIS PHARMS. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Feb 12, 2026approval181d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

    Sponsor: ALKEM. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Feb 12, 2026approval181d agoADQUEY (DIFAMILAST) — FDA approvaldifamilast

    Sponsor: ACROTECH BIOPHARMA. Form: OINTMENT. Route: TOPICAL

    full page →difamilast →fda approvals ↗
    ›Feb 12, 2026approval181d agoGLATOPA (GLATIRAMER ACETATE) — FDA approvalGLATIRAMER ACETATE

    Sponsor: SANDOZ. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →GLATIRAMER ACETATE →fda approvals ↗
    ›Feb 12, 2026approval181d agoENZEEVU (AFLIBERCEPT-ABZV) — FDA approvalaflibercept biosimilar

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

    full page →aflibercept biosimilar →fda approvals ↗
    ›Feb 12, 2026approval181d agoBIJUVA (ESTRADIOL) — FDA approval(estradiol + progesterone)

    Sponsor: MAYNE PHARMA. Form: CAPSULE. Route: ORAL

    full page →(estradiol + progesterone) →fda approvals ↗
    ›Feb 12, 2026approval181d agoESTRING (ESTRADIOL) — FDA approvalestradiol ER

    Sponsor: PFIZER. Form: INSERT, EXTENDED RELEASE. Route: VAGINAL

    full page →estradiol ER →fda approvals ↗
    ›Feb 12, 2026approval181d agoPEPCID AC (FAMOTIDINE) — FDA approvalKenvue Inc.

    Sponsor: KENVUE BRANDS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Feb 12, 2026approval181d agoAMMONIUM LACTATE — FDA approvalAMMONIUM LACTATE

    Sponsor: ZYDUS LIFESCIENCES. Form: CREAM. Route: TOPICAL

    full page →AMMONIUM LACTATE →fda approvals ↗
    ›Feb 12, 2026approval181d agoGLATOPA (GLATIRAMER ACETATE) — FDA approvalGLATIRAMER ACETATE

    Sponsor: SANDOZ. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →GLATIRAMER ACETATE →fda approvals ↗
    ›Feb 12, 2026approval181d agoDIVIGEL (ESTRADIOL) — FDA approvalVertical Pharmaceuticals LLC

    Sponsor: VERTICAL PHARMS. Form: GEL. Route: TRANSDERMAL

    full page →fda approvals ↗
    ›Feb 12, 2026approval181d agoCENESTIN (ESTROGENS, CONJUGATED SYNTHETIC A) — FDA approvalCENESTIN

    Sponsor: ASPEN. Form: TABLET. Route: ORAL

    full page →CENESTIN →fda approvals ↗
    ›Feb 12, 2026approval181d agoDARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ) — FDA approval(daratumumab + hyaluronidase (human recombinant))

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

    full page →(daratumumab + hyaluronidase (human recombinant)) →fda approvals ↗
    ›Feb 12, 2026approval181d agoCELECOXIB — FDA approvalScilex Holding Co

    Sponsor: QINGDAO BAHEAL PHARM. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Feb 12, 2026device 510k181d agoSZ KKS Silicone&Electronic Co., Ltd. — LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k181d agoWell-Life Healthcare , Ltd. — Well-Life Incontinence Stimulation System (WL-2405i(P)) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k181d agoXenocor, Inc. — Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) (510k cleared)Xencor Inc

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k181d agoRoche Diagnostics — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k181d agoTianjin Huahong Technology Co., Ltd. — Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k181d agoGuangzhou Hehong Biotech Co., Ltd. — Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k181d agoRoche Diagnostics — ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k181d agoKarl Storz SE & CO. KG — IMAGE1 (TC400US); X-to-4U Adapter (TC040) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k181d agoStryker Endoscopy — L12 LED Light Source with AIM (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k181d ago4Web, Inc. — Lumbar Spine Truss System - Plating Solution (LSTS-PS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k181d agoMedtronic Navigation, Inc. — Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k181d agoPuracath Medical, Inc. — PuraCath Firefly Needleless Connector IT (9005) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k181d agoHealgen Scientific,, LLC — Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device 510k181d agoMet One Technologies, LLC — Wrist Fracture System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 12, 2026device pma181d agoMedtronic, Inc. — Melody Transcatheter Pulmonary Valve (PMA supplement)Medtronic plc

    Supplement type: 135 Review Track For 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Feb 12, 2026device pma181d agoMedtronic, Inc. — Avalus Bioprostheses (PMA supplement)Medtronic plc

    Supplement type: 135 Review Track For 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Feb 12, 2026device pma181d agoEdwards Lifesciences, LLC — Edwards Commander Delivery System (9600LDS20, 9600LDS23 9600LDS26, 9600LDS29) (PMA supplement)Edwards Lifesciences Corp

    Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 12, 2026device pma181d agoAxora Medical, Inc. — Minerva Endometrial Ablation System (PMA supplement)AVITA Medical, Inc.

    Supplement type: 30-Day Notice. Product code: MNB. Advisory committee: OB. Decision: OK30

    full page →fda device pma ↗
    ›Feb 12, 2026device pma181d agoAbbott Laboratories — ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92) (PMA supplement)ABBOTT LABORATORIES

    Supplement type: 30-Day Notice. Product code: MTF. Advisory committee: IM. Decision: OK30

    full page →fda device pma ↗
    ›Feb 12, 2026device pma181d agoIntegrum AB — OPRA Implant System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 12, 2026device pma181d agoBoston Scientific Corp — WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: 30-Day Notice. Product code: NGV. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 12, 2026device pma181d agoABBOTT MEDICAL — Amplatzer™ Amulet™ Left Atrial Appendage Occluder (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NGV. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 12, 2026device pma181d agoMedtronic, Inc. — Aurora EV ICD DVEA3E4 (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 12, 2026device pma181d agoAbbott Laboratories — ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (PMA supplement)ABBOTT LABORATORIES

    Supplement type: 30-Day Notice. Product code: LOK. Advisory committee: IM. Decision: OK30

    full page →fda device pma ↗
    ›Feb 12, 2026device pma181d agoBiotronik, Inc. — Solia CSP S 53; Solia CSP S 60 (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: NVN. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Feb 12, 2026device pma181d agoMedtronic, Inc. — Hancock II Bioprosthesis (PMA supplement)Medtronic plc

    Supplement type: 135 Review Track For 30-Day Notice. Product code: DYE. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Feb 12, 2026device pma181d agoMedtronic Neuromodulation — SNS Urinary Neurostimulator Models 97800, 97810; SNS Urinary Screening Trialing Systems Model 3531 (PMA supplement)

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

    full page →fda device pma ↗
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    $BSX51.32+1.70%
    $ABT109.83+1.11%
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