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calendar

18,993 catalysts · 18,987 approval · 7,115 phase readout · 5,000 device 510k · 4,728 grant · 3,583 8k filing · 2,000 device pma

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  • approval18,987
  • phase readout7,115
  • device 510k5,000
  • grant4,728
  • 8k filing3,583
  • device pma2,000
  • device recall
2,000
  • recall1,126
  • device adverse event1,000
  • earnings585
  • therapy area
    • Ophthalmology5

    Week of Feb 10, 2025

    15
    ›Feb 11, 2025approval564d agoEVRYSDI (RISDIPLAM) — FDA approvalEVRYSDI

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

    full page →EVRYSDI →fda approvals ↗
    ›Feb 11, 2025approval564d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Feb 11, 2025approval564d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

    Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL

    full page →fda approvals ↗
    ›Feb 12, 2025approval563d agoMETHYLPREDNISOLONE ACETATE — FDA approvalMETHYLPREDNISOLONE ACETATE

    Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

    full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗
    ›Feb 12, 2025approval563d agoMETHYLPREDNISOLONE ACETATE — FDA approvalMETHYLPREDNISOLONE ACETATE

    Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

    full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗
    ›Feb 12, 2025approval563d agoIZERVAY (AVACINCAPTAD PEGOL SODIUM) — FDA approvalavacincaptad pegol sodium

    Sponsor: ASTELLAS. Form: SOLUTION. Route: INTRAVITREAL

    full page →avacincaptad pegol sodium →fda approvals ↗
    ›Feb 12, 2025approval563d agoPAXLOVID (COPACKAGED) (NIRMATRELVIR) — FDA approvalPAXLOVID (COPACKAGED)

    Sponsor: PFIZER. Form: TABLET. Route: ORAL

    full page →PAXLOVID (COPACKAGED) →fda approvals ↗
    ›Feb 12, 2025approval563d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

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

    full page →fda approvals ↗
    ›Feb 12, 2025approval563d agoVICTOZA (LIRAGLUTIDE) — FDA approvalSaxenda

    Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →Saxenda →fda approvals ↗
    ›Feb 12, 2025approval563d agoACETYLCYSTEINE — FDA approvalACETYLCYSTEINE

    Sponsor: SOMERSET THERAPS LLC. Form: SOLUTION. Route: INHALATION, ORAL

    full page →ACETYLCYSTEINE →fda approvals ↗
    ›Feb 13, 2025approval562d agoTRUQAP (CAPIVASERTIB) — FDA approvalcapivasertib

    Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL

    full page →capivasertib →fda approvals ↗
    ›Feb 13, 2025approval562d agoDENOSUMAB-DSSB — FDA approvaldenosumab biosimilar

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

    full page →denosumab biosimilar →fda approvals ↗
    ›Feb 14, 2025approval561d agoROMVIMZA (VIMSELTINIB) — FDA approvalDeciphera Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Feb 14, 2025approval561d agoRYBREVANT (AMIVANTAMAB-VMJW) — FDA approvalamivantamab

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

    full page →amivantamab →fda approvals ↗
    ›Feb 14, 2025approval561d agoSIMLANDI (ADALIMUMAB-RYVK) — FDA approvalAlvotech

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

    full page →fda approvals ↗

    Week of Feb 17, 2025

    35
    ›Feb 18, 2025approval557d agoATROPINE SULFATE — FDA approvalATROPINE SULFATE

    Sponsor: ACCORD HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

    full page →ATROPINE SULFATE →fda approvals ↗
    ›Feb 18, 2025approval
    ← prev
    page 320 of 380
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    557d ago
    LORBRENA (LORLATINIB) — FDA approvallorlatinib

    Sponsor: PFIZER. Form: TABLET. Route: ORAL

    full page →lorlatinib →fda approvals ↗
    ›Feb 19, 2025approval556d agoOTULFI (USTEKINUMAB-AAUZ) — FDA approvalOTULFI

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

    full page →OTULFI →fda approvals ↗
    ›Feb 19, 2025approval556d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Feb 19, 2025approval556d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Feb 21, 2025approval554d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

    Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL

    full page →fda approvals ↗
    ›Feb 21, 2025approval554d agoBOSENTAN — FDA approvalBOSENTAN

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

    full page →BOSENTAN →fda approvals ↗
    ›Feb 21, 2025approval554d agoBOSENTAN — FDA approvalZydus Therapeutics Inc

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

    full page →fda approvals ↗
    ›Feb 21, 2025approval554d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

    full page →fda approvals ↗
    ›Feb 21, 2025approval554d agoCARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER (NICARDIPINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: CHIESI. Form: INJECTABLE. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Feb 21, 2025approval554d agoXELJANZ XR (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

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

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Feb 21, 2025approval554d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

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

    full page →fda approvals ↗
    ›Feb 21, 2025approval554d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

    Sponsor: PFIZER. Form: SOLUTION. Route: ORAL

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Feb 21, 2025approval554d agoBOSENTAN — FDA approvalBOSENTAN

    Sponsor: NATCO PHARMA LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →BOSENTAN →fda approvals ↗
    ›Feb 21, 2025approval554d agoBOSENTAN — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Feb 21, 2025approval554d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

    full page →fda approvals ↗
    ›Feb 21, 2025approval554d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

    Sponsor: ACTELION. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Feb 21, 2025approval554d agoBOSENTAN — FDA approvalBOSENTAN

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

    full page →BOSENTAN →fda approvals ↗
    ›Feb 21, 2025approval554d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

    full page →fda approvals ↗
    ›Feb 21, 2025approval554d agoSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 21, 2025approval554d agoSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 21, 2025approval554d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval554d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval554d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Feb 21, 2025approval554d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Feb 21, 2025approval554d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

    Sponsor: RHODES PHARMS. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›Feb 21, 2025approval554d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval554d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Feb 21, 2025approval554d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval554d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval554d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval554d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Feb 21, 2025approval554d agoSUBLOCADE (BUPRENORPHINE) — FDA approvalbuprenorphine LA

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

    full page →buprenorphine LA →fda approvals ↗
    ›Feb 21, 2025approval554d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval554d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

    Sponsor: RHODES PHARMS. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    $PFE28.03-0.96%
    $KVUE19.20-0.10%
    $IGC0.2670+0.41%
    $ALVO4.8800-0.61%
    $NVO47.19-3.02%
    $AZN164.52-1.05%
    $ALVO4.8800-0.61%
    $AMRX17.99+0.39%
    $PFE28.03-0.96%
    $PFE28.03-0.96%
    $AMRX17.99+0.39%
    $IGC0.2670+0.41%
    $PFE28.03-0.96%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $INDV35.30-1.47%
    $IGC0.2670+0.41%
    $NSRX2.7000-1.82%
    $NSRX2.7000-1.82%