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10,372 catalysts · 3,286 8k filing · 2,098 grant · 1,170 approval · 1,000 device adverse event · 885 device 510k · 633 device pma

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  • 8k filing3,286
  • grant2,098
  • approval1,170
  • device adverse event1,000
  • device 510k885
  • device pma633
earnings
584
  • device recall415
  • recall220
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jan 19, 2026

    50
    ›Jan 22, 2026approval204d agoATORVASTATIN CALCIUM — FDA approvalSciegen Pharmaceuticals Inc

    Sponsor: SCIEGEN PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jan 22, 2026approval204d agoKETOROLAC TROMETHAMINE — FDA approvalKetorolac Tromethamine Apotex

    Sponsor: APOTEX. Form: SOLUTION/DROPS. Route: OPHTHALMIC

    full page →Ketorolac Tromethamine Apotex →fda approvals ↗
    ›Jan 22, 2026approval204d agoOLANZAPINE — FDA approvalolanzapine ODT

    Sponsor: CADILA PHARMS LTD. Form: TABLET. Route: ORAL

    full page →olanzapine ODT →fda approvals ↗
    ›Jan 22, 2026approval204d agoOXAPROZIN — FDA approvalSolubiomix LLC

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

    full page →fda approvals ↗
    ›Jan 22, 2026approval204d agoTEMOZOLOMIDE — FDA approvalAreva Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jan 22, 2026approval204d agoTEMOZOLOMIDE — FDA approvalAreva Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jan 22, 2026approval204d agoACYCLOVIR — FDA approvalACYCLOVIR

    Sponsor: APOTEX. Form: CAPSULE. Route: ORAL

    full page →ACYCLOVIR →fda approvals ↗
    ›Jan 22, 2026approval204d agoAMLODIPINE BESYLATE — FDA approvalChina Resources Saike Pharmaceutical Co Ltd

    Sponsor: TEVA PHARMS INC. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jan 22, 2026approval204d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

    full page →METHADONE HYDROCHLORIDE →fda approvals ↗
    ›Jan 22, 2026approval204d agoOSELTAMIVIR PHOSPHATE — FDA approvalF. Hoffmann-La Roche Ltd

    Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 22, 2026approval204d agoZILBRYSQ (ZILUCOPLAN SODIUM) — FDA approvalzilucoplan

    Sponsor: UCB INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →zilucoplan →fda approvals ↗
    ›Jan 22, 2026approval204d agoROPINIROLE HYDROCHLORIDE — FDA approvalElite Laboratories Inc

    Sponsor: CHARTWELL RX. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 22, 2026approval204d agoROPINIROLE HYDROCHLORIDE — FDA approvalElite Laboratories Inc

    Sponsor: CHARTWELL RX. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 22, 2026approval204d agoESTRADIOL — FDA approvalestradiol ER

    Sponsor: EPIC PHARMA LLC. Form: TABLET. Route: ORAL

    full page →estradiol ER →fda approvals ↗
    ›Jan 22, 2026device 510k204d agoImplant Protesis Dental 2004, S.L. — IPDmilled Blanks (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k204d agoLima Corporate S.P.A. — SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k204d agoMaquet GmbH (A Getinge Group Company) — Getinge GSS67N Series Steam Sterilizer (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k204d agoCultiv8 1, LLC — Genie MAX Large Bore Introducer Sheath (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k204d agoGeistlich Pharma AG — Device 104 Particulate (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k204d agoMedela, LLC — Pump In Style® Pro+ (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k204d agoAstura Medical — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k204d agoPerin Health Devices, LLC — Perin Health System (PHD80060-2) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k204d agoSiemens Healthcare GmbH — AI-Rad Companion Brain MR (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k204d agoPhilips Medical Systems Nederland B.V. — AV Vascular (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k204d agoCopan Wasp Srl — PhenoMATRIX (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device 510k204d agoInstitut Straumann AG — Straumann Variobase Abutments XC for Bridge/Bar (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 22, 2026device pma204d agoETHICON, Inc. — ETHIZIA™ Hemostatic Patch (PMA supplement)

    Supplement type: 30-Day Notice. Product code: SGV. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Jan 22, 2026device pma204d agoBoston Scientific Corp — Precision Spinal Cord Stimulator (SCS) Systems (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jan 22, 2026device pma204d agoBoston Scientific Corp — Vercise Deep Brain Stimulation (DBS) Systems (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Jan 22, 2026device pma204d agoEndologix, LLC — DETOUR System (PMA supplement)

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

    full page →fda device pma ↗
    ›Jan 23, 2026approval203d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

    Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

    full page →fda approvals ↗
    ›Jan 23, 2026approval203d agoEPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

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

    full page →EPYSQLI →fda approvals ↗
    ›Jan 23, 2026approval203d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

    Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Jan 23, 2026approval203d agoOLANZAPINE — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

    Sponsor: OMNIVIUM PHARMS. Form: POWDER. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›Jan 23, 2026approval203d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalnaloxone hydrochloride

    Sponsor: LUPIN. Form: TABLET. Route: ORAL

    full page →naloxone hydrochloride →fda approvals ↗
    ›Jan 23, 2026approval203d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalnaloxone hydrochloride

    Sponsor: LUPIN. Form: TABLET. Route: ORAL

    full page →naloxone hydrochloride →fda approvals ↗
    ›Jan 23, 2026approval203d agoAFREZZA (INSULIN RECOMBINANT HUMAN) — FDA approvalinsulin human

    Sponsor: MANNKIND. Form: POWDER. Route: INHALATION

    full page →insulin human →fda approvals ↗
    ›Jan 23, 2026approval203d agoJOURNAVX (SUZETRIGINE) — FDA approvalsuzetrigine

    Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

    full page →suzetrigine →fda approvals ↗
    ›Jan 23, 2026device 510k203d agoAb Medica Sas — Pneumo Dissector Hook (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k203d agoRandox Laboratories Limited — Evidence MultiSTAT DOA Urine MultiPlex (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k203d agoPoint Robotics MedTech, Inc. — POINT Kinguide Agile Robotic Arm Surgical Stereotactic System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k203d agoDevicor Medical Products, Inc. — HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (510k cleared)UTAH MEDICAL PRODUCTS INC

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k203d agoBoston Scientific Cardiac Diagnostic Technologies, Inc. — BodyGuardian Remote Monitoring System (BGRMS v3.0) (510k cleared)BOSTON SCIENTIFIC CORP

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k203d agoBasic Medical Technology, Inc. — Syntex Exam Gloves (510k cleared)Medical Care Technologies Inc.

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k203d agoManteia Technologies Co., Ltd. — AccuContour 4.0 (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k203d agoSilk Holdings, Inc. — New Day Skin Spray (510k cleared)SILGAN HOLDINGS INC

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k203d agoLife Spine, Inc. — Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k203d agoShenzhen Rainbow Technology Co., Ltd. — LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k203d agoGe Healthcare Coils (Usa Instruments, Inc.) — 3.0T AIR 32CH HNA (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 23, 2026device 510k203d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
    page 15 of 208
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    $CPIX7.8700-0.51%
    $UTMD69.19+0.06%
    $BSX51.39-0.07%
    $MNKD3.6850-4.29%
    $VERX12.59+2.36%
    $TEVA37.09+0.95%
    $BSX51.39-0.07%
    $BSX51.39-0.07%
    $SLGN
    $MDCE0.00020.00%
    $FRTRY