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18,993 catalysts · 18,987 approval · 7,115 phase readout · 5,000 device 510k · 4,728 grant · 3,590 8k filing · 2,000 device pma

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  • approval18,987
  • phase readout7,115
  • device 510k5,000
  • grant4,728
  • 8k filing3,590
  • device pma2,000
  • device recall
2,000
  • recall1,126
  • device adverse event1,000
  • earnings585
  • therapy area
    • Ophthalmology5

    Week of Aug 4, 2025

    13
    ›Aug 5, 2025approval389d agoPOMALIDOMIDE — FDA approvalPOMALIDOMIDE

    Sponsor: MYLAN. Form: CAPSULE. Route: ORAL

    full page →POMALIDOMIDE →fda approvals ↗
    ›Aug 6, 2025approval388d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

    Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Aug 6, 2025approval388d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

    Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Aug 6, 2025approval388d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Aug 6, 2025approval388d agoLAMOTRIGINE — FDA approvalTorrent Pharma Inc

    Sponsor: UNICHEM LABS LTD. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Aug 6, 2025approval388d agoIBANDRONATE SODIUM — FDA approvalDR REDDYS LABORATORIES LTD

    Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Aug 6, 2025approval388d agoZTALMY (GANAXOLONE) — FDA approvalganaxolone

    Sponsor: IMMEDICA PHARMA. Form: SUSPENSION. Route: ORAL

    full page →ganaxolone →fda approvals ↗
    ›Aug 7, 2025approval387d agoPRUCALOPRIDE SUCCINATE — FDA approvalPRUCALOPRIDE SUCCINATE

    Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL

    full page →PRUCALOPRIDE SUCCINATE →fda approvals ↗
    ›Aug 8, 2025approval386d agoSODIUM ACETATE — FDA approvalSODIUM ACETATE

    Sponsor: AMNEAL. Form: SOLUTION. Route: INTRAVENOUS

    full page →SODIUM ACETATE →fda approvals ↗
    ›Aug 8, 2025approval386d agoHERNEXEOS (ZONGERTINIB) — FDA approvalzongertinib

    Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

    full page →zongertinib →fda approvals ↗
    ›Aug 8, 2025approval386d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

    full page →tocilizumab →fda approvals ↗
    ›Aug 8, 2025approval386d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

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

    full page →tocilizumab →fda approvals ↗
    ›Aug 8, 2025approval386d agoIRON SUCROSE — FDA approvalsuccharated ferric oxide

    Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

    full page →succharated ferric oxide →fda approvals ↗

    Week of Aug 11, 2025

    8
    ›Aug 11, 2025approval383d agoDEFLAZACORT — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Aug 12, 2025approval

    Week of Aug 18, 2025

    15
    ›Aug 18, 2025approval376d agoKESIMPTA (OFATUMUMAB) — FDA approvalKESIMPTA

    Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →KESIMPTA →fda approvals ↗
    ›Aug 18, 2025approval

    Week of Aug 25, 2025

    5
    ›Aug 25, 2025approval369d agoOPUVIZ (AFLIBERCEPT-YSZY) — FDA approvalOPUVIZ

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

    full page →OPUVIZ →fda approvals ↗
    ›Aug 26, 2025approval

    Week of Sep 1, 2025

    7
    ›Sep 2, 2025approval361d agoEPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

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

    full page →EPYSQLI →fda approvals ↗
    ›Sep 3, 2025approval

    Week of Sep 8, 2025

    2
    ›Sep 9, 2025approval354d agoTEPEZZA (TEPROTUMUMAB-TRBW) — FDA approvalteprotumumab

    Sponsor: HORIZON THERAPEUTICS IRELAND. Form: INJECTABLE. Route: INJECTION

    full page →teprotumumab →fda approvals ↗
    ›Sep 10, 2025approval
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    page 328 of 380
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    382d ago
    RINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

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

    full page →upadacitinib tartrate ER →fda approvals ↗
    ›Aug 14, 2025approval380d agoOTULFI (USTEKINUMAB-AAUZ) — FDA approvalOTULFI

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

    full page →OTULFI →fda approvals ↗
    ›Aug 14, 2025approval380d agoOTULFI (USTEKINUMAB-AAUZ) — FDA approvalOTULFI

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

    full page →OTULFI →fda approvals ↗
    ›Aug 14, 2025approval380d agoLAZCLUZE (LAZERTINIB MESYLATE) — FDA approvallazertinib mesylate

    Sponsor: JANSSEN BIOTECH. Form: TABLET. Route: ORAL

    full page →lazertinib mesylate →fda approvals ↗
    ›Aug 14, 2025approval380d agoRYBREVANT (AMIVANTAMAB-VMJW) — FDA approvalamivantamab

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

    full page →amivantamab →fda approvals ↗
    ›Aug 15, 2025approval379d agoBYOOVIZ (RANIBIZUMAB-NUNA) — FDA approvalBYOOVIZ

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

    full page →BYOOVIZ →fda approvals ↗
    ›Aug 15, 2025approval379d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    376d ago
    BRIUMVI (UBLITUXIMAB-XIIY) — FDA approvalublituximab

    Sponsor: TG THERAPEUTICS, INC. Form: INJECTABLE. Route: INTRAVENOUS

    full page →ublituximab →fda approvals ↗
    ›Aug 18, 2025approval376d agoBRIUMVI (UBLITUXIMAB-XIIY) — FDA approvalublituximab

    Sponsor: TG THERAPEUTICS, INC. Form: INJECTABLE. Route: INTRAVENOUS

    full page →ublituximab →fda approvals ↗
    ›Aug 18, 2025approval376d agoTECENTRIQ 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 ↗
    ›Aug 18, 2025approval376d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

    full page →atezolizumab →fda approvals ↗
    ›Aug 18, 2025approval376d agoVYEPTI (EPTINEZUMAB-JJMR) — FDA approvalH. Lundbeck AS

    Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Aug 19, 2025approval375d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

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

    full page →teclistamab →fda approvals ↗
    ›Aug 19, 2025approval375d agoTALVEY (TALQUETAMAB-TGVS) — FDA approvaltalquetamab

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

    full page →talquetamab →fda approvals ↗
    ›Aug 21, 2025approval373d agoIMCIVREE (SETMELANOTIDE ACETATE) — FDA approvalsetmelanotide

    Sponsor: RHYTHM. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →setmelanotide →fda approvals ↗
    ›Aug 21, 2025approval373d agoLEQEMBI (LECANEMAB-IRMB) — FDA approvallecanemab

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

    full page →lecanemab →fda approvals ↗
    ›Aug 21, 2025approval373d agoCEFAZOLIN SODIUM — FDA approvalSamson Medical Technologies LLC

    Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Aug 21, 2025approval373d agoCEFAZOLIN SODIUM — FDA approvalSamson Medical Technologies LLC

    Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Aug 21, 2025approval373d agoCEFAZOLIN SODIUM — FDA approvalSamson Medical Technologies LLC

    Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Aug 22, 2025approval372d agoVONJO (PACRITINIB CITRATE) — FDA approvalpacritinib

    Sponsor: SOBI. Form: CAPSULE. Route: ORAL

    full page →pacritinib →fda approvals ↗
    ›Aug 22, 2025approval372d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

    Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: INTRAVENOUS

    full page →remdesivir →fda approvals ↗
    368d ago
    TEPEZZA (TEPROTUMUMAB-TRBW) — FDA approvalteprotumumab

    Sponsor: HORIZON THERAPEUTICS IRELAND. Form: INJECTABLE. Route: INJECTION

    full page →teprotumumab →fda approvals ↗
    ›Aug 27, 2025approval367d agoFILSPARI (SPARSENTAN) — FDA approvalsparsentan

    Sponsor: TRAVERE. Form: TABLET. Route: ORAL

    full page →sparsentan →fda approvals ↗
    ›Aug 29, 2025approval365d agoBRIXADI (BUPRENORPHINE) — FDA approvalbuprenorphine LA

    Sponsor: BRAEBURN. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS

    full page →buprenorphine LA →fda approvals ↗
    ›Aug 29, 2025approval365d agoBILPREVDA (DENOSUMAB-NXXP) — FDA approvalBILPREVDA

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

    full page →BILPREVDA →fda approvals ↗
    360d ago
    SKYRIZI (RISANKIZUMAB-RZAA) — FDA approvalrisankizumab

    Sponsor: ABBVIE INC. Form: INJECTABLE. Route: INTRAVENOUS

    full page →risankizumab →fda approvals ↗
    ›Sep 3, 2025approval360d agoSKYRIZI (RISANKIZUMAB-RZAA) — FDA approvalrisankizumab

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

    full page →risankizumab →fda approvals ↗
    ›Sep 3, 2025approval360d agoVIGAFYDE (VIGABATRIN) — FDA approvalPyros Pharmaceuticals Inc.

    Sponsor: PYROS PHARMS. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Sep 3, 2025approval360d agoVIGAFYDE (VIGABATRIN) — FDA approvalPyros Pharmaceuticals Inc.

    Sponsor: PYROS PHARMS. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Sep 3, 2025approval360d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

    Sponsor: RUBICON RESEARCH. Form: TABLET. Route: ORAL

    full page →tramadol hydrochloride ER →fda approvals ↗
    ›Sep 3, 2025approval360d agoRYBREVANT (AMIVANTAMAB-VMJW) — FDA approvalamivantamab

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

    full page →amivantamab →fda approvals ↗
    353d ago
    KOSELUGO (SELUMETINIB SULFATE) — FDA approvalselumetinib sulfate

    Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL

    full page →selumetinib sulfate →fda approvals ↗
    $AMRX17.99+0.39%
    $RDY12.19-0.29%
    $NVS157.54-1.53%
    $AMRX17.99+0.39%
    $NVS157.54-1.53%
    $NVS157.54-1.53%
    $TVTX67.12+0.16%
    $RYTM110.90-0.87%
    $TGTX55.72+1.25%
    $ABBV259.04-1.47%
    $TGTX55.72+1.25%
    $ABBV259.04-1.47%
    $GILD147.94-0.10%
    $AZN164.52-1.05%
    $ABBV259.04-1.47%