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23,559 catalysts · 5,000 device 510k · 4,728 grant · 3,888 approval · 3,152 8k filing · 2,000 device pma · 2,000 device recall

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  • device 510k5,000
  • grant4,728
  • approval3,888
  • 8k filing3,152
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • earnings584
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    • Oncology148
    • Infectious Disease46
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    • Dermatology31
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    • Women's Health19
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    Week of Sep 16, 2024

    24
    ›Sep 17, 2024approval695d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

    Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

    full page →pembrolizumab →fda approvals ↗
    ›Sep 17, 2024approval695d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

    full page →fda approvals ↗
    ›Sep 17, 2024approval695d agoBOSENTAN — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: AMNEAL PHARMS CO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Sep 17, 2024approval695d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

    full page →fda approvals ↗
    ›Sep 17, 2024approval695d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

    Sponsor: ACTELION. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Sep 17, 2024approval695d agoBOSENTAN — FDA approvalBOSENTAN

    Sponsor: NATCO PHARMA LTD. Form: TABLET. Route: ORAL

    full page →BOSENTAN →fda approvals ↗
    ›Sep 17, 2024approval695d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

    Sponsor: ACTELION. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Sep 17, 2024approval695d agoEVRYSDI (RISDIPLAM) — FDA approvalEVRYSDI

    Sponsor: GENENTECH INC. Form: FOR SOLUTION. Route: ORAL

    full page →EVRYSDI →fda approvals ↗
    ›Sep 19, 2024approval693d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: SANALUZ. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Sep 19, 2024approval693d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Sep 19, 2024approval693d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Sep 19, 2024approval693d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Sep 19, 2024approval693d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

    Sponsor: SOMERSET THERAPS LLC. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

    full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗
    ›Sep 19, 2024approval693d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

    Sponsor: SOMERSET THERAPS LLC. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

    full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗
    ›Sep 19, 2024approval693d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

    full page →tocilizumab →fda approvals ↗
    ›Sep 19, 2024approval693d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

    full page →tocilizumab →fda approvals ↗
    ›Sep 19, 2024approval693d agoPYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

    Sponsor: LABS JUVISE. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Sep 19, 2024approval693d agoRYBREVANT (AMIVANTAMAB-VMJW) — FDA approvalamivantamab

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

    full page →amivantamab →fda approvals ↗
    ›Sep 19, 2024approval693d agoKINERET (ANAKINRA) — FDA approvalSobi Inc

    Sponsor: BIOVITRUM AB. Form: VIAL. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Sep 19, 2024approval693d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

    Sponsor: ALEXION PHARM. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Sep 20, 2024approval692d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

    full page →tocilizumab →fda approvals ↗
    ›Sep 20, 2024approval692d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

    full page →tocilizumab →fda approvals ↗
    ›Sep 20, 2024approval692d agoCABENUVA KIT (CABOTEGRAVIR) — FDA approvalViiV Healthcare Company

    Sponsor: VIIV HLTHCARE. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›Sep 20, 2024approval692d agoDIAMOX (ACETAZOLAMIDE) — FDA approvalAccord Healthcare Inc

    Sponsor: TEVA BRANDED PHARM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗

    Week of Sep 23, 2024

    26
    ›Sep 23, 2024approval689d agoTRUQAP (CAPIVASERTIB) — FDA approvalcapivasertib

    Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL

    full page →capivasertib →fda approvals ↗
    ›Sep 24, 2024approval
    ← prev
    page 7 of 472
    next →
    688d ago
    FLUOROURACIL — FDA approvalExtrovis AG

    Sponsor: KINDOS. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Sep 25, 2024approval687d agoWAINUA (AUTOINJECTOR) (EPLONTERSEN SODIUM) — FDA approvaleplontersen sodium

    Sponsor: ASTRAZENECA AB. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →eplontersen sodium →fda approvals ↗
    ›Sep 26, 2024approval686d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

    Sponsor: AUROBINDO PHARMA LTD. Form: FOR SUSPENSION. Route: ORAL

    full page →MYCOPHENOLATE MOFETIL →fda approvals ↗
    ›Sep 26, 2024approval686d agoPOMALIDOMIDE — FDA approvalPOMALIDOMIDE

    Sponsor: HETERO LABS LTD V. Form: CAPSULE. Route: ORAL

    full page →POMALIDOMIDE →fda approvals ↗
    ›Sep 26, 2024approval686d agoNALBUPHINE HYDROCHLORIDE — FDA approvalTrevi Therapeutics, Inc.

    Sponsor: DR REDDYS. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

    full page →fda approvals ↗
    ›Sep 26, 2024device 510k686d agoAccelerate Diagnostics, Inc. — Accelerate Arc System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2024device 510k686d agoMolli Surgical, Inc. — MOLLI 2 System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2024device 510k686d agoSpineguard — Cannulated PsiFGuard (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024approval685d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

    Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

    full page →dupilumab →fda approvals ↗
    ›Sep 27, 2024approval685d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

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

    full page →ALENDRONATE SODIUM →fda approvals ↗
    ›Sep 27, 2024approval685d agoXELJANZ XR (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

    Sponsor: PFIZER. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Sep 27, 2024approval685d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

    Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Sep 27, 2024approval685d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

    Sponsor: PFIZER. Form: SOLUTION. Route: ORAL

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Sep 27, 2024approval685d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

    Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

    full page →UNASYN →fda approvals ↗
    ›Sep 27, 2024approval685d agoOTULFI (USTEKINUMAB-AAUZ) — FDA approvalOTULFI

    Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

    full page →OTULFI →fda approvals ↗
    ›Sep 27, 2024approval685d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

    Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

    full page →selpercatinib →fda approvals ↗
    ›Sep 27, 2024approval685d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

    Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

    full page →selpercatinib →fda approvals ↗
    ›Sep 27, 2024approval685d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

    Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

    full page →selpercatinib →fda approvals ↗
    ›Sep 27, 2024approval685d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

    Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

    full page →selpercatinib →fda approvals ↗
    ›Sep 27, 2024device 510k685d agoHangzhou AllTest Biotech Co., Ltd. — AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel (510k cleared)Hangzhou DAC Biotech Co Ltd

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k685d agoWestridge Laboratories, Inc. — ID Free Personal Lubricant (510k cleared)G&W Laboratories Inc

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k685d agoBrain Electrophysiology Laboratory Company, LLC — Sourcerer (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k685d agoShockwave Medical, Inc. — Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k685d agoO&M Halyard, Inc. — Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k685d agoNanosonics Limited — trophon Wireless Ultrasound Probe Holder (510k cleared)

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

    full page →fda device 510k ↗
    $NSRX2.7000-1.82%
    $AZN157.56-0.75%
    $AMRX17.10-4.36%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $PFE26.62-1.59%
    $TRVI17.91+0.62%
    $PFE26.62-1.59%
    $AZN157.56-0.75%
    $REGN797.00-1.37%
    $LLY1215.02-1.37%
    $LLY1215.02-1.37%
    $LLY1215.02-1.37%
    $LLY1215.02-1.37%