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calendar

18,993 catalysts · 18,987 approval · 7,115 phase readout · 5,000 device 510k · 4,728 grant · 3,561 8k filing · 2,000 device pma

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  • approval18,987
  • phase readout7,115
  • device 510k5,000
  • grant4,728
  • 8k filing3,561
  • device pma2,000
  • device recall
2,000
  • recall1,126
  • device adverse event1,000
  • earnings585
  • therapy area
    • Ophthalmology5

    Week of Sep 16, 2024

    21
    ›Sep 17, 2024approval710d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

    full page →fda approvals ↗
    ›Sep 17, 2024approval710d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

    Sponsor: ACTELION. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Sep 17, 2024approval710d agoBOSENTAN — FDA approvalBOSENTAN

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

    full page →BOSENTAN →fda approvals ↗
    ›Sep 17, 2024approval710d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

    full page →fda approvals ↗
    ›Sep 17, 2024approval710d agoEVRYSDI (RISDIPLAM) — FDA approvalEVRYSDI

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

    full page →EVRYSDI →fda approvals ↗
    ›Sep 19, 2024approval708d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: SANALUZ. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Sep 19, 2024approval708d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Sep 19, 2024approval708d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Sep 19, 2024approval708d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Sep 19, 2024approval708d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

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

    full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗
    ›Sep 19, 2024approval708d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

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

    full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗
    ›Sep 19, 2024approval708d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

    full page →tocilizumab →fda approvals ↗
    ›Sep 19, 2024approval708d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

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

    full page →tocilizumab →fda approvals ↗
    ›Sep 19, 2024approval708d agoPYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

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

    full page →fda approvals ↗
    ›Sep 19, 2024approval708d agoRYBREVANT (AMIVANTAMAB-VMJW) — FDA approvalamivantamab

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

    full page →amivantamab →fda approvals ↗
    ›Sep 19, 2024approval708d agoKINERET (ANAKINRA) — FDA approvalSobi Inc

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

    full page →fda approvals ↗
    ›Sep 19, 2024approval708d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Sep 20, 2024approval707d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

    full page →tocilizumab →fda approvals ↗
    ›Sep 20, 2024approval707d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

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

    full page →tocilizumab →fda approvals ↗
    ›Sep 20, 2024approval707d agoCABENUVA KIT (CABOTEGRAVIR) — FDA approvalViiV Healthcare Company

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

    full page →fda approvals ↗
    ›Sep 20, 2024approval707d agoDIAMOX (ACETAZOLAMIDE) — FDA approvalAccord Healthcare Inc

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

    full page →fda approvals ↗

    Week of Sep 23, 2024

    17
    ›Sep 23, 2024approval704d agoTRUQAP (CAPIVASERTIB) — FDA approvalcapivasertib

    Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL

    full page →capivasertib →fda approvals ↗
    ›Sep 24, 2024approval

    Week of Sep 30, 2024

    12
    ›Sep 30, 2024approval697d agoDAYBUE (TROFINETIDE) — FDA approvaltrofinetide

    Sponsor: ACADIA PHARMS INC. Form: SOLUTION. Route: ORAL

    full page →trofinetide →fda approvals ↗
    ›Sep 30, 2024approval
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    page 309 of 380
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    703d ago
    FLUOROURACIL — FDA approvalExtrovis AG

    Sponsor: KINDOS. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Sep 25, 2024approval702d agoWAINUA (AUTOINJECTOR) (EPLONTERSEN SODIUM) — FDA approvaleplontersen sodium

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

    full page →eplontersen sodium →fda approvals ↗
    ›Sep 26, 2024approval701d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

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

    full page →MYCOPHENOLATE MOFETIL →fda approvals ↗
    ›Sep 26, 2024approval701d agoPOMALIDOMIDE — FDA approvalPOMALIDOMIDE

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

    full page →POMALIDOMIDE →fda approvals ↗
    ›Sep 26, 2024approval701d agoNALBUPHINE HYDROCHLORIDE — FDA approvalTrevi Therapeutics, Inc.

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

    full page →fda approvals ↗
    ›Sep 27, 2024approval700d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

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

    full page →dupilumab →fda approvals ↗
    ›Sep 27, 2024approval700d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

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

    full page →ALENDRONATE SODIUM →fda approvals ↗
    ›Sep 27, 2024approval700d 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, 2024approval700d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

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

    full page →fda approvals ↗
    ›Sep 27, 2024approval700d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

    Sponsor: PFIZER. Form: SOLUTION. Route: ORAL

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Sep 27, 2024approval700d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

    Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

    full page →UNASYN →fda approvals ↗
    ›Sep 27, 2024approval700d agoOTULFI (USTEKINUMAB-AAUZ) — FDA approvalOTULFI

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

    full page →OTULFI →fda approvals ↗
    ›Sep 27, 2024approval700d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

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

    full page →selpercatinib →fda approvals ↗
    ›Sep 27, 2024approval700d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

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

    full page →selpercatinib →fda approvals ↗
    ›Sep 27, 2024approval700d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

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

    full page →selpercatinib →fda approvals ↗
    ›Sep 27, 2024approval700d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

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

    full page →selpercatinib →fda approvals ↗
    697d ago
    DAYBUE (TROFINETIDE) — FDA approvaltrofinetide

    Sponsor: ACADIA PHARMS INC. Form: SOLUTION. Route: ORAL

    full page →trofinetide →fda approvals ↗
    ›Oct 1, 2024approval696d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Oct 1, 2024approval696d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Oct 2, 2024approval695d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalANI PHARMACEUTICALS INC

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

    full page →fda approvals ↗
    ›Oct 3, 2024approval694d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

    Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

    full page →nivolumab →fda approvals ↗
    ›Oct 3, 2024approval694d agoHYDROCODONE BITARTRATE AND ASPIRIN (ASPIRIN) — FDA approvalPurdue Pharma LP

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

    full page →fda approvals ↗
    ›Oct 3, 2024approval694d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

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

    full page →hydrocodone bitartrate ER →fda approvals ↗
    ›Oct 3, 2024approval694d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

    Sponsor: ACTAVIS LABS FL INC. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 3, 2024approval694d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

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

    full page →fda approvals ↗
    ›Oct 3, 2024approval694d agoBUTORPHANOL TARTRATE — FDA approvalBUTORPHANOL TARTRATE

    Sponsor: RISING. Form: SPRAY, METERED. Route: NASAL

    full page →BUTORPHANOL TARTRATE →fda approvals ↗
    ›Oct 3, 2024approval694d agoGABAPENTIN — FDA approvalGABAPENTIN

    Sponsor: ZYDUS PHARMS USA INC. Form: TABLET. Route: ORAL

    full page →GABAPENTIN →fda approvals ↗
    $AZN166.27-2.00%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $NSRX2.7000-1.82%
    $ACAD29.57-0.04%
    $LLY1189.41-3.59%
    $REGN813.63-0.14%
    $TRVI17.92-0.17%
    $AZN166.27-2.00%
    $IGC0.2670+0.41%
    $LLY1189.41-3.59%
    $LLY1189.41-3.59%
    $ACAD29.57-0.04%
    $NVS157.54-1.53%
    $NVS157.54-1.53%
    $ANIP73.85-0.95%
    $BMY67.25-0.48%
    $LLY1189.41-3.59%
    $PFE28.03-0.96%
    $PFE28.03-0.96%