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calendar

7,581 catalysts · 4,728 grant · 3,364 device 510k · 3,124 8k filing · 2,853 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 95 catalysts2026-08-12: 19 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 2 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: approval×type: grant×from 2025-04-02×clear all
type
  • grant4,728
  • device 510k3,364
  • 8k filing3,124
  • approval2,853
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall848
  • earnings583
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Mar 31, 2025

    12
    ›Apr 2, 2025approval497d agoVANRAFIA (ATRASENTAN HYDROCHLORIDE) — FDA approvalatrasentan hydrochloride

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →atrasentan hydrochloride →fda approvals ↗
    ›Apr 2, 2025approval497d agoLIRAGLUTIDE — FDA approvalNovo Nordisk Inc

    Sponsor: NANJING KING FRIEND. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Apr 2, 2025approval497d agoLIDOCAINE HYDROCHLORIDE — FDA approvalInternational Medication Systems Ltd

    Sponsor: ANTHEA PHARMA. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Apr 3, 2025approval496d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Apr 3, 2025approval496d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: WES PHARMA INC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Apr 3, 2025approval496d agoUPLIZNA (INEBILIZUMAB-CDON) — FDA approvalHorizon Therapeutics USA Inc

    Sponsor: VIELA BIO. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Apr 4, 2025approval495d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

    Sponsor: CUBIST PHARMS LLC. Form: TABLET. Route: ORAL

    full page →tedizolid phosphate →fda approvals ↗
    ›Apr 4, 2025approval495d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

    Sponsor: CUBIST PHARMS LLC. Form: POWDER. Route: INTRAVENOUS

    full page →tedizolid phosphate →fda approvals ↗
    ›Apr 4, 2025approval495d agoAMBRISENTAN — FDA approvalAMBRISENTAN

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

    full page →AMBRISENTAN →fda approvals ↗
    ›Apr 4, 2025approval495d agoAMBRISENTAN — FDA approvalAMBRISENTAN

    Sponsor: SIGMAPHARM LABS LLC. Form: TABLET. Route: ORAL

    full page →AMBRISENTAN →fda approvals ↗
    ›Apr 4, 2025approval495d agoAMBRISENTAN — FDA approvalSigmapharm Laboratories LLC

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

    full page →fda approvals ↗
    ›Apr 4, 2025approval495d agoAMBRISENTAN — FDA approvalAMBRISENTAN

    Sponsor: APOTEX. Form: TABLET. Route: ORAL

    full page →AMBRISENTAN →fda approvals ↗

    Week of Apr 7, 2025

    17
    ›Apr 7, 2025approval492d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Apr 7, 2025approval

    Week of Apr 14, 2025

    11
    ›Apr 14, 2025approval485d agoOTULFI (USTEKINUMAB-AAUZ) — FDA approvalOTULFI

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

    full page →OTULFI →fda approvals ↗
    ›Apr 14, 2025approval

    Week of Apr 21, 2025

    10
    ›Apr 21, 2025approval478d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›Apr 21, 2025approval
    ← prev
    page 1 of 152
    next →
    492d ago
    TAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

    Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

    full page →dabrafenib mesylate ODT →fda approvals ↗
    ›Apr 7, 2025approval492d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Apr 7, 2025approval492d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

    Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

    full page →dabrafenib mesylate ODT →fda approvals ↗
    ›Apr 7, 2025approval492d agoSIMLANDI (ADALIMUMAB-RYVK) — FDA approvalAlvotech

    Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Apr 7, 2025approval492d agoSIMLANDI (ADALIMUMAB-RYVK) — FDA approvalAlvotech

    Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Apr 7, 2025approval492d agoAMJEVITA (ADALIMUMAB-ATTO) — FDA approvalAMJEVITA

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

    full page →AMJEVITA →fda approvals ↗
    ›Apr 7, 2025approval492d agoYUFLYMA (ADALIMUMAB-AATY) — FDA approvalYUFLYMA

    Sponsor: CELLTRION. Form: INJECTABLE. Route: INJECTION

    full page →YUFLYMA →fda approvals ↗
    ›Apr 8, 2025approval491d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗
    ›Apr 8, 2025approval491d agoFINTEPLA (FENFLURAMINE HYDROCHLORIDE) — FDA approvalfenfluramine hydrochloride

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

    full page →fenfluramine hydrochloride →fda approvals ↗
    ›Apr 10, 2025approval489d agoVYVGART HYTRULO (EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC) — FDA approvalARGENX SE

    Sponsor: ARGENX BV. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Apr 10, 2025approval489d agoTEPADINA AND SODIUM CHLORIDE (THIOTEPA) — FDA approvalRevalesio Corp

    Sponsor: ADIENNE SA. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Apr 10, 2025approval489d agoLOPRESSOR (METOPROLOL TARTRATE) — FDA approvalmetoprolol tartrate

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

    full page →metoprolol tartrate →fda approvals ↗
    ›Apr 11, 2025approval488d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗
    ›Apr 11, 2025approval488d agoSUBLOCADE (BUPRENORPHINE) — FDA approvalbuprenorphine LA

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

    full page →buprenorphine LA →fda approvals ↗
    ›Apr 11, 2025approval488d agoMORPHINE SULFATE — FDA approvalKapanol

    Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →Kapanol →fda approvals ↗
    ›Apr 11, 2025approval488d agoCABENUVA KIT (CABOTEGRAVIR) — FDA approvalViiV Healthcare Company

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

    full page →fda approvals ↗
    485d ago
    ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 15, 2025approval484d agoISTURISA (OSILODROSTAT PHOSPHATE) — FDA approvalosilodrostat phosphate

    Sponsor: RECORDATI RARE. Form: TABLET. Route: ORAL

    full page →osilodrostat phosphate →fda approvals ↗
    ›Apr 15, 2025approval484d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

    Sponsor: SUNSHINE. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Apr 16, 2025approval483d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

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

    full page →dupilumab →fda approvals ↗
    ›Apr 16, 2025approval483d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

    Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Apr 17, 2025approval482d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

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

    full page →dupilumab →fda approvals ↗
    ›Apr 18, 2025approval481d agoWAINUA (AUTOINJECTOR) (EPLONTERSEN SODIUM) — FDA approvaleplontersen sodium

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

    full page →eplontersen sodium →fda approvals ↗
    ›Apr 18, 2025approval481d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

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

    full page →eculizumab biosimilar →fda approvals ↗
    ›Apr 18, 2025approval481d agoOJJAARA (MOMELOTINIB DIHYDROCHLORIDE) — FDA approvalmomelotinib dihydrochloride

    Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

    full page →momelotinib dihydrochloride →fda approvals ↗
    ›Apr 18, 2025approval481d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

    Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    478d ago
    MEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Apr 22, 2025approval477d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

    Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

    full page →fda approvals ↗
    ›Apr 22, 2025approval477d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

    Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

    full page →fda approvals ↗
    ›Apr 22, 2025approval477d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

    Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

    full page →fda approvals ↗
    ›Apr 22, 2025approval477d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

    Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

    full page →fda approvals ↗
    ›Apr 22, 2025approval477d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

    Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

    full page →fda approvals ↗
    ›Apr 22, 2025approval477d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

    Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

    full page →fda approvals ↗
    ›Apr 24, 2025approval475d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

    Sponsor: BAYER. Form: TABLET. Route: ORAL

    full page →NAPROXEN SODIUM →fda approvals ↗
    ›Apr 25, 2025approval474d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

    Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    $NVS155.21-1.01%
    $NVS155.21-1.01%
    $IGC0.2670+0.41%
    $NVS155.21-1.01%
    $NVS155.21-1.01%
    $AMGN414.03-0.76%
    $ALVO3.8200+1.33%
    $ALVO3.8200+1.33%
    $NVS155.21-1.01%
    $IGC0.2670+0.41%
    $BMY63.75-1.68%
    $ARGX863.55-0.30%
    $INDV39.20+1.90%
    $BMY63.75-1.68%
    $NVS155.21-1.01%
    $AZN159.50-1.49%
    $AMGN414.03-0.76%
    $ONC361.49+0.69%
    $ONC361.49+0.69%
    $REGN802.21-0.72%
    $ONC361.49+0.69%
    $REGN802.21-0.72%
    $ONC361.49+0.69%
    $ONC361.49+0.69%
    $ONC361.49+0.69%