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calendar

4,213 catalysts · 3,356 8k filing · 2,370 grant · 1,843 approval · 1,245 device 510k · 1,000 device adverse event · 880 device pma

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type: approval×type: grant×from 2025-11-21×clear all
type
  • 8k filing3,356
  • grant2,370
  • approval1,843
  • device 510k1,245
  • device adverse event1,000
  • device pma880
device recall
718
  • earnings584
  • recall307
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Nov 17, 2025

    20
    ›Nov 21, 2025approval269d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›Nov 21, 2025approval269d agoKEYTRUDA QLEX (PEMBROLIZUMAB) — FDA approval(berahyaluronidase alfa + pembrolizumab)

    Sponsor: MERCK SHARP DOHME. Form: INJECTABLE. Route: INJECTION

    full page →(berahyaluronidase alfa + pembrolizumab) →fda approvals ↗
    ›Nov 21, 2025approval269d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Nov 21, 2025approval269d agoNARCAN (NALOXONE HYDROCHLORIDE) — FDA approvalEmergent Devices Inc

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

    full page →fda approvals ↗
    ›Nov 21, 2025approval269d agoNEXLETOL (BEMPEDOIC ACID) — FDA approvalbempedoic acid

    Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

    full page →bempedoic acid →fda approvals ↗
    ›Nov 21, 2025approval269d agoNEXLIZET (BEMPEDOIC ACID) — FDA approval(bempedoic acid + ezetimibe)

    Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

    full page →(bempedoic acid + ezetimibe) →fda approvals ↗
    ›Nov 21, 2025approval269d agoLIVTENCITY (MARIBAVIR) — FDA approvalTakeda Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 21, 2025approval269d agoURSODIOL — FDA approvalURSODIOL

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

    full page →URSODIOL →fda approvals ↗
    ›Nov 21, 2025approval269d agoUNLOXCYT (COSIBELIMAB-IPDL) — FDA approvalcosibelimab

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

    full page →cosibelimab →fda approvals ↗
    ›Nov 21, 2025approval269d agoDALFAMPRIDINE — FDA approvalSolaxa Inc

    Sponsor: ALKEM LABS LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Nov 21, 2025approval269d agoFULVESTRANT — FDA approvalFULVESTRANT

    Sponsor: AVYXA HOLDINGS. Form: SOLUTION. Route: INTRAMUSCULAR

    full page →FULVESTRANT →fda approvals ↗
    ›Nov 21, 2025approval269d agoBACLOFEN — FDA approvalBACLOFEN

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

    full page →BACLOFEN →fda approvals ↗
    ›Nov 21, 2025approval269d agoPYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

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

    full page →fda approvals ↗
    ›Nov 21, 2025approval269d agoAKTEN (LIDOCAINE HYDROCHLORIDE) — FDA approvalLaryng-O-Jet

    Sponsor: THEA PHARMA. Form: GEL. Route: OPHTHALMIC

    full page →Laryng-O-Jet →fda approvals ↗
    ›Nov 21, 2025approval269d agoDEFLAZACORT — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Nov 21, 2025approval269d agoLEVETIRACETAM — FDA approvalAprecia Pharmaceuticals LLC

    Sponsor: ANDA REPOSITORY. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Nov 21, 2025approval269d agoPADCEV (ENFORTUMAB VEDOTIN-EJFV) — FDA approvalenfortumab vedotin

    Sponsor: ASTELLAS. Form: INJECTABLE. Route: INJECTION

    full page →enfortumab vedotin →fda approvals ↗
    ›Nov 21, 2025approval269d agoDIPRIVAN (PROPOFOL) — FDA approvalPROPOFOL

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

    full page →PROPOFOL →fda approvals ↗
    ›Nov 21, 2025approval269d agoALBUTEROL SULFATE — FDA approvalALBUTEROL SULFATE

    Sponsor: CIPLA. Form: AEROSOL, METERED. Route: INHALATION

    full page →ALBUTEROL SULFATE →fda approvals ↗
    ›Nov 21, 2025approval269d agoQOLIANA (BRIMONIDINE TARTRATE) — FDA approvalLumify

    Sponsor: SANDOZ. Form: SOLUTION/DROPS. Route: OPHTHALMIC

    full page →Lumify →fda approvals ↗

    Week of Nov 24, 2025

    30
    ›Nov 24, 2025approval266d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

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

    full page →eculizumab biosimilar →fda approvals ↗
    ›Nov 24, 2025approval
    ← prev
    page 1 of 85
    next →
    266d ago
    HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Nov 24, 2025approval266d agoOLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE) — FDA approvalamlodipine besylate

    Sponsor: MICRO LABS. Form: TABLET. Route: ORAL

    full page →amlodipine besylate →fda approvals ↗
    ›Nov 24, 2025approval266d agoONDANSETRON — FDA approvalondansetron ODT

    Sponsor: AUROBINDO PHARMA. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →ondansetron ODT →fda approvals ↗
    ›Nov 24, 2025approval266d agoSYNAREL (NAFARELIN ACETATE) — FDA approvalnafarelin acetate

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

    full page →nafarelin acetate →fda approvals ↗
    ›Nov 24, 2025approval266d 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 ↗
    ›Nov 24, 2025approval266d agoONDANSETRON — FDA approvalSandoz Inc

    Sponsor: SUN PHARM INDS LTD. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →fda approvals ↗
    ›Nov 24, 2025approval266d agoOPDIVO QVANTIG (NIVOLUMAB) — FDA approval(hyaluronidase (recombinant, human) + nivolumab)

    Sponsor: BRISTOL-MYERS SQUIBB. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →(hyaluronidase (recombinant, human) + nivolumab) →fda approvals ↗
    ›Nov 24, 2025approval266d agoCLADRIBINE — FDA approvalCLADRIBINE

    Sponsor: APOTEX. Form: TABLET. Route: ORAL

    full page →CLADRIBINE →fda approvals ↗
    ›Nov 24, 2025approval266d agoTECHNESCAN PYP KIT (TECHNETIUM TC-99M PYROPHOSPHATE KIT) — FDA approval

    Sponsor: CURIUM. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Nov 24, 2025approval266d agoTECHNESCAN HDP (TECHNETIUM TC-99M OXIDRONATE KIT) — FDA approval

    Sponsor: CURIUM. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Nov 24, 2025approval266d agoTAZAROTENE — FDA approvalTAZAROTENE

    Sponsor: SOLARIS PHARMA CORP. Form: CREAM. Route: TOPICAL

    full page →TAZAROTENE →fda approvals ↗
    ›Nov 24, 2025approval266d agoTEPEZZA (TEPROTUMUMAB-TRBW) — FDA approvalteprotumumab

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

    full page →teprotumumab →fda approvals ↗
    ›Nov 24, 2025approval266d agoGABAPENTIN — FDA approvalGABAPENTIN

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

    full page →GABAPENTIN →fda approvals ↗
    ›Nov 24, 2025approval266d agoVERAPAMIL HYDROCHLORIDE — FDA approvalCalan

    Sponsor: ZYDUS LIFESCIENCES. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →Calan →fda approvals ↗
    ›Nov 25, 2025approval265d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Nov 25, 2025approval265d agoTIZANIDINE HYDROCHLORIDE — FDA approvalZydus Therapeutics Inc

    Sponsor: ZYDUS PHARMS. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Nov 25, 2025approval265d agoHUMATROPE (SOMATROPIN) — FDA approvalEMD Serono Inc

    Sponsor: LILLY. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Nov 25, 2025approval265d agoPRED MILD (PREDNISOLONE ACETATE) — FDA approvalprednisolone acetate

    Sponsor: ABBVIE. Form: SUSPENSION/DROPS. Route: OPHTHALMIC

    full page →prednisolone acetate →fda approvals ↗
    ›Nov 25, 2025approval265d agoZEGERID OTC (OMEPRAZOLE) — FDA approvalCovis Pharmaceuticals Inc (Inactive)

    Sponsor: RILEY CONSUMER. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Nov 25, 2025approval265d agoENOXAPARIN SODIUM (PRESERVATIVE FREE) (ENOXAPARIN SODIUM) — FDA approvalenoxaparin sodium

    Sponsor: SHENZHEN TECHDOW. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →enoxaparin sodium →fda approvals ↗
    ›Nov 25, 2025approval265d agoIRBESARTAN — FDA approvalIRBESARTAN

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

    full page →IRBESARTAN →fda approvals ↗
    ›Nov 25, 2025approval265d agoSCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approvalasciminib hydrochloride

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →asciminib hydrochloride →fda approvals ↗
    ›Nov 25, 2025approval265d agoVOYXACT (SIBEPRENLIMAB-SZSI) — FDA approvalsibeprenlimab

    Sponsor: OTSUKA PHARM CO LTD. Form: INJECTABLE. Route: INJECTION

    full page →sibeprenlimab →fda approvals ↗
    ›Nov 25, 2025approval265d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

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

    full page →fda approvals ↗
    ›Nov 25, 2025approval265d agoACETAZOLAMIDE — FDA approvalAccord Healthcare Inc

    Sponsor: HIBROW HLTHCARE. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 25, 2025approval265d agoCHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE) — FDA approvalKenvue Inc.

    Sponsor: BAJAJ. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Nov 25, 2025approval265d agoPERAMPANEL — FDA approvalCATALYST PHARMACEUTICALS, INC.

    Sponsor: TARO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 25, 2025approval265d agoNOREPINEPHRINE BITARTRATE — FDA approvalBaxter Healthcare Corp

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

    full page →fda approvals ↗
    ›Nov 25, 2025approval265d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

    full page →ALDACTAZIDE →fda approvals ↗
    $CCCC
    $ESPR
    $AMGN415.21-0.63%
    $AMRX18.15+5.10%
    $ESPR
    $IGC0.2670+0.41%
    $PFE26.79-0.04%
    $AZN156.45-0.50%
    $IGC0.2670+0.41%
    $ABBV249.46-0.54%
    $BMY63.83-1.27%
    $CPRX31.490.00%
    $NVS150.88-0.55%
    $KVUE19.200.00%