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calendar

7,920 catalysts · 4,728 grant · 4,428 device 510k · 3,606 8k filing · 3,192 approval · 2,000 device pma · 2,000 device recall

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type: approval×type: grant×from 2024-11-27×clear all
type
  • grant4,728
  • device 510k4,428
  • 8k filing3,606
  • approval3,192
  • device pma2,000
  • device recall2,000
recall
1,093
  • device adverse event1,000
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Nov 25, 2024

    4
    ›Nov 27, 2024approval643d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Nov 29, 2024approval641d agoYESINTEK (USTEKINUMAB-KFCE) — FDA approvalustekinumab biosimilar

    Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION

    full page →ustekinumab biosimilar →fda approvals ↗
    ›Nov 29, 2024approval641d agoDAYTRANA (METHYLPHENIDATE) — FDA approvalNoven Pharmaceuticals Inc

    Sponsor: NOVEN PHARMS INC. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

    full page →fda approvals ↗
    ›Nov 29, 2024approval641d agoXELSTRYM (DEXTROAMPHETAMINE) — FDA approvalNoven Pharmaceuticals Inc

    Sponsor: NOVEN PHARMS INC. Form: SYSTEM. Route: TRANSDERMAL

    full page →fda approvals ↗

    Week of Dec 2, 2024

    9
    ›Dec 2, 2024approval638d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

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

    full page →teclistamab →fda approvals ↗
    ›Dec 2, 2024approval

    Week of Dec 9, 2024

    13
    ›Dec 9, 2024approval631d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

    Sponsor: NOVO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 9, 2024approval

    Week of Dec 16, 2024

    24
    ›Dec 16, 2024approval624d agoDEPO-SUBQ PROVERA 104 (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

    Sponsor: PFIZER. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →medroxyprogesterone acetate →fda approvals ↗
    ›Dec 17, 2024approval
    ← prev
    page 1 of 159
    next →
    638d ago
    TALVEY (TALQUETAMAB-TGVS) — FDA approvaltalquetamab

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

    full page →talquetamab →fda approvals ↗
    ›Dec 2, 2024approval638d agoAXTLE (PEMETREXED DIPOTASSIUM) — FDA approvalAXTLE

    Sponsor: AVYXA HOLDINGS. Form: POWDER. Route: INTRAVENOUS

    full page →AXTLE →fda approvals ↗
    ›Dec 3, 2024approval637d agoBOSULIF (BOSUTINIB MONOHYDRATE) — FDA approvalAlembic Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Dec 3, 2024approval637d agoBOSULIF (BOSUTINIB MONOHYDRATE) — FDA approvalAlembic Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Dec 3, 2024approval637d agoVABOMERE (MEROPENEM) — FDA approvalHQ Speciality Pharma

    Sponsor: REMPEX. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Dec 3, 2024approval637d agoTYENNE (TOCILIZUMAB-AAZG) — FDA approvalTYENNE

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

    full page →TYENNE →fda approvals ↗
    ›Dec 4, 2024approval636d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

    Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Dec 6, 2024approval634d agoISOVUE-250 (IOPAMIDOL) — FDA approval

    Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    631d ago
    OZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

    Sponsor: NOVO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 9, 2024approval631d agoERTUGLIFLOZIN — FDA approvalERTUGLIFLOZIN

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

    full page →ERTUGLIFLOZIN →fda approvals ↗
    ›Dec 9, 2024approval631d agoPREGABALIN — FDA approvalPREGABALIN

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

    full page →PREGABALIN →fda approvals ↗
    ›Dec 10, 2024approval630d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

    full page →tocilizumab →fda approvals ↗
    ›Dec 10, 2024approval630d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

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

    full page →tocilizumab →fda approvals ↗
    ›Dec 10, 2024approval630d agoHEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HEPARIN SODIUM) — FDA approvalHEPARIN SODIUM

    Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

    full page →HEPARIN SODIUM →fda approvals ↗
    ›Dec 11, 2024approval629d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›Dec 12, 2024approval628d agoNURTEC ODT (RIMEGEPANT SULFATE) — FDA approvalrimegepant sulfate ODT

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

    full page →rimegepant sulfate ODT →fda approvals ↗
    ›Dec 13, 2024approval627d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

    Sponsor: VERTEX PHARMS INC. Form: GRANULE. Route: ORAL

    full page →(ivacaftor + lumacaftor) →fda approvals ↗
    ›Dec 13, 2024approval627d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

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

    full page →(ivacaftor + lumacaftor) →fda approvals ↗
    ›Dec 13, 2024approval627d agoTYENNE (TOCILIZUMAB-AAZG) — FDA approvalTYENNE

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

    full page →TYENNE →fda approvals ↗
    ›Dec 13, 2024approval627d agoUNLOXCYT (COSIBELIMAB-IPDL) — FDA approvalcosibelimab

    Sponsor: CHECKPOINT THERAPEUTICS INC. Form: INJECTABLE. Route: INJECTION

    full page →cosibelimab →fda approvals ↗
    623d ago
    GABAPENTIN — FDA approvalAlmatica Pharma LLC

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

    full page →fda approvals ↗
    ›Dec 17, 2024approval623d agoVIGABATRIN — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Dec 17, 2024approval623d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Dec 17, 2024approval623d agoSTEQEYMA (USTEKINUMAB-STBA) — FDA approvalSTEQEYMA

    Sponsor: CELLTRION, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →STEQEYMA →fda approvals ↗
    ›Dec 17, 2024approval623d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

    Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

    full page →blinatumomab →fda approvals ↗
    ›Dec 18, 2024approval622d agoENSACOVE (ENSARTINIB HYDROCHLORIDE) — FDA approvalensartinib hydrochloride

    Sponsor: XCOVERY. Form: CAPSULE. Route: ORAL

    full page →ensartinib hydrochloride →fda approvals ↗
    ›Dec 18, 2024approval622d agoIDACIO (ADALIMUMAB-AACF) — FDA approvalIDACIO

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

    full page →IDACIO →fda approvals ↗
    ›Dec 18, 2024approval622d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

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

    full page →selpercatinib →fda approvals ↗
    ›Dec 18, 2024approval622d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

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

    full page →selpercatinib →fda approvals ↗
    ›Dec 19, 2024approval621d agoGABAPENTIN — FDA approvalGABAPENTIN

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

    full page →GABAPENTIN →fda approvals ↗
    ›Dec 19, 2024approval621d agoGABAPENTIN — FDA approvalGABAPENTIN

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

    full page →GABAPENTIN →fda approvals ↗
    ›Dec 19, 2024approval621d agoGABAPENTIN — FDA approvalGABAPENTIN

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

    full page →GABAPENTIN →fda approvals ↗
    ›Dec 19, 2024approval621d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

    Sponsor: ALKEM. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 19, 2024approval621d agoCEREZYME (IMIGLUCERASE) — FDA approvalimiglucerase

    Sponsor: GENZYME. Form: INJECTABLE. Route: INJECTION

    full page →imiglucerase →fda approvals ↗
    ›Dec 19, 2024approval621d agoGABAPENTIN — FDA approvalGABAPENTIN

    Sponsor: SANDOZ. Form: CAPSULE. Route: ORAL

    full page →GABAPENTIN →fda approvals ↗
    ›Dec 19, 2024approval621d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

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

    full page →remdesivir →fda approvals ↗
    ›Dec 20, 2024approval620d agoSKYCLARYS (OMAVELOXOLONE) — FDA approvalReata Pharmaceuticals Inc

    Sponsor: BIOGEN US. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 20, 2024approval620d agoSKYCLARYS (OMAVELOXOLONE) — FDA approvalReata Pharmaceuticals Inc

    Sponsor: BIOGEN US. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 20, 2024approval620d agoALYFTREK (DEUTIVACAFTOR) — FDA approval(deutivacaftor + tezacaftor + vanzacaftor calcium)

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

    full page →(deutivacaftor + tezacaftor + vanzacaftor calcium) →fda approvals ↗
    ›Dec 20, 2024approval620d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

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

    full page →TRIKAFTA (COPACKAGED) →fda approvals ↗
    ›Dec 20, 2024approval620d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

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

    full page →TRIKAFTA (COPACKAGED) →fda approvals ↗
    ›Dec 20, 2024approval620d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

    Sponsor: VERTEX PHARMS INC. Form: GRANULES. Route: ORAL

    full page →TRIKAFTA (COPACKAGED) →fda approvals ↗
    ›Dec 20, 2024approval620d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

    Sponsor: VERTEX PHARMS INC. Form: GRANULES. Route: ORAL

    full page →TRIKAFTA (COPACKAGED) →fda approvals ↗
    $HCWB
    $PFE27.96-0.21%
    $AZN162.70-1.11%
    $PFE27.96-0.21%
    $CCCC
    $VERX14.22-0.52%
    $VERX14.22-0.52%
    $AMGN432.42-1.05%
    $AMRX17.54-2.61%
    $LLY1174.61-0.13%
    $LLY1174.61-0.13%
    $VERX14.22-0.52%
    $GILD145.68-2.14%
    $VERX14.22-0.52%
    $VERX14.22-0.52%
    $VERX14.22-0.52%
    $VERX14.22-0.52%