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18,994 catalysts · 18,987 approval · 7,208 phase readout · 5,000 device 510k · 4,728 grant · 3,603 8k filing · 2,000 device pma

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type: pdufa×type: approval×clear all
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  • approval18,987
  • phase readout7,208
  • device 510k5,000
  • grant4,728
  • 8k filing3,603
  • device pma2,000
  • device recall
2,000
  • recall1,126
  • device adverse event1,000
  • earnings585
  • therapy area
    • Dermatology1
    • Infectious Disease1

    Week of Nov 10, 2025

    44
    ›Nov 13, 2025approval290d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

    Sponsor: RISING. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

    full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗
    ›Nov 13, 2025approval290d agoATORVASTATIN CALCIUM — FDA approvalViatris Inc

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

    full page →fda approvals ↗
    ›Nov 13, 2025approval290d agoVERAPAMIL HYDROCHLORIDE — FDA approvalCalan

    Sponsor: ASPIRO. Form: INJECTABLE. Route: INJECTION

    full page →Calan →fda approvals ↗
    ›Nov 13, 2025approval290d agoKOMZIFTI (ZIFTOMENIB) — FDA approvalKura Oncology, Inc.

    Sponsor: KURA. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Nov 13, 2025approval290d agoONDANSETRON — FDA approvalSandoz Inc

    Sponsor: IPCA LABS LTD. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →fda approvals ↗
    ›Nov 13, 2025approval290d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalondansetron hydrochloride CR

    Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INJECTION

    full page →ondansetron hydrochloride CR →fda approvals ↗
    ›Nov 13, 2025approval290d agoBRIVARACETAM — FDA approvalBRIVARACETAM

    Sponsor: MSN. Form: TABLET. Route: ORAL

    full page →BRIVARACETAM →fda approvals ↗
    ›Nov 13, 2025approval290d agoPOHERDY (PERTUZUMAB-DPZB) — FDA approvalpertuzumab biosimilar

    Sponsor: SHANGHAI HENLIUS BIOTECH. Form: INJECTABLE. Route: INTRAVENOUS

    full page →pertuzumab biosimilar →fda approvals ↗
    ›Nov 13, 2025approval290d agoLEUPROLIDE ACETATE — FDA approvalZydus Therapeutics Inc

    Sponsor: ZYDUS PHARMS. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Nov 13, 2025approval290d agoONDANSETRON — FDA approvalSandoz Inc

    Sponsor: BARR. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →fda approvals ↗
    ›Nov 13, 2025approval290d agoRALDESY (TRAZODONE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: KAMAT. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Nov 13, 2025approval290d agoIOHEXOL — FDA approvalIOHEXOL

    Sponsor: AMNEAL. Form: SOLUTION. Route: INJECTION, ORAL, RECTAL

    full page →IOHEXOL →fda approvals ↗
    ›Nov 14, 2025approval289d agoDANZITEN (NILOTINIB TARTRATE) — FDA approvalDANZITEN

    Sponsor: AZURITY. Form: TABLET. Route: ORAL

    full page →DANZITEN →fda approvals ↗
    ›Nov 14, 2025approval289d 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 ↗
    ›Nov 14, 2025approval289d agoALDACTAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

    Sponsor: PFIZER. Form: TABLET. Route: ORAL

    full page →ALDACTAZIDE →fda approvals ↗
    ›Nov 14, 2025approval289d agoLUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: ABBVIE ENDOCRINE INC. Form: POWDER. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoDIAZEPAM — FDA approvalDIAZEPAM

    Sponsor: NAVINTA LLC. Form: GEL. Route: RECTAL

    full page →DIAZEPAM →fda approvals ↗
    ›Nov 14, 2025approval289d agoLENALIDOMIDE — FDA approvalLENALIDOMIDE

    Sponsor: ACCORD HLTHCARE. Form: CAPSULE. Route: ORAL

    full page →LENALIDOMIDE →fda approvals ↗
    ›Nov 14, 2025approval289d agoDIPHENHYDRAMINE HYDROCHLORIDE — FDA approvalPAI Holding Co LLC

    Sponsor: AVET LIFESCIENCES. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoARIPIPRAZOLE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 14, 2025approval289d agoFOSFOMYCIN TROMETHAMINE — FDA approvalFOSFOMYCIN TROMETHAMINE

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

    full page →FOSFOMYCIN TROMETHAMINE →fda approvals ↗
    ›Nov 14, 2025approval289d agoALDACTONE (SPIRONOLACTONE) — FDA approvalALDACTONE

    Sponsor: PFIZER. Form: TABLET. Route: ORAL

    full page →ALDACTONE →fda approvals ↗
    ›Nov 14, 2025approval289d agoDILTIAZEM HYDROCHLORIDE — FDA approvalDILTIAZEM HYDROCHLORIDE

    Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

    full page →DILTIAZEM HYDROCHLORIDE →fda approvals ↗
    ›Nov 14, 2025approval289d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Nov 14, 2025approval289d agoVORICONAZOLE — FDA approvalVORICONAZOLE

    Sponsor: HAINAN POLY PHARM. Form: SOLUTION. Route: INTRAVENOUS

    full page →VORICONAZOLE →fda approvals ↗
    ›Nov 14, 2025approval289d agoRIVAROXABAN — FDA approvalRIVAROXABAN

    Sponsor: APOTEX. Form: TABLET. Route: ORAL

    full page →RIVAROXABAN →fda approvals ↗
    ›Nov 14, 2025approval289d agoTRUQAP (CAPIVASERTIB) — FDA approvalcapivasertib

    Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL

    full page →capivasertib →fda approvals ↗

    Week of Nov 17, 2025

    6
    ›Nov 17, 2025approval286d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

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

    full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗
    ›Nov 17, 2025approval
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    286d ago
    TECENTRIQ HYBREZA (ATEZOLIZUMAB AND HYALURONIDASE-TQJS) — FDA approval(atezolizumab + hyaluronidase (human recombinant))

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

    full page →(atezolizumab + hyaluronidase (human recombinant)) →fda approvals ↗
    ›Nov 17, 2025approval286d agoLOPERAMIDE HYDROCHLORIDE — FDA approvalLOPERAMIDE HYDROCHLORIDE

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

    full page →LOPERAMIDE HYDROCHLORIDE →fda approvals ↗
    ›Nov 17, 2025approval286d agoTOFACITINIB CITRATE — FDA approvaltofacitinib citrate ER

    Sponsor: BIOCON PHARMA. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Nov 17, 2025approval286d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

    Sponsor: GLAND PHARMA LTD. Form: INJECTABLE. Route: INJECTION

    full page →ondansetron hydrochloride CR →fda approvals ↗
    ›Nov 17, 2025approval286d agoMEMBRANEBLUE (TRYPAN BLUE) — FDA approval

    Sponsor: DORC. Form: SOLUTION. Route: OPHTHALMIC

    full page →fda approvals ↗
    $VTRS16.34-3.26%
    $KURA13.18+0.92%
    $AMRX17.54-2.61%
    $PFE27.96-0.21%
    $AZN164.52-1.05%
    $AMRX17.54-2.61%
    $PFE27.96-0.21%