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calendar

18,993 catalysts · 18,987 approval · 7,208 phase readout · 5,000 device 510k · 4,728 grant · 3,603 8k filing · 2,000 device pma

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  • approval18,987
  • phase readout7,208
  • device 510k5,000
  • grant4,728
  • 8k filing3,603
  • device pma2,000
  • device recall
2,000
  • recall1,126
  • device adverse event1,000
  • earnings585
  • therapy area
    • Ophthalmology5

    Week of Sep 29, 2025

    17
    ›Oct 2, 2025approval331d agoLIDOCAINE HYDROCHLORIDE — FDA approvalInternational Medication Systems Ltd

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

    full page →fda approvals ↗
    ›Oct 2, 2025approval331d agoPILOCARPINE HYDROCHLORIDE — FDA approvalPILOCARPINE HYDROCHLORIDE

    Sponsor: FDC LTD. Form: SOLUTION/DROPS. Route: OPHTHALMIC

    full page →PILOCARPINE HYDROCHLORIDE →fda approvals ↗
    ›Oct 2, 2025approval331d agoOSELTAMIVIR PHOSPHATE — FDA approvalF. Hoffmann-La Roche Ltd

    Sponsor: ZHEJIANG POLY PHARM. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Oct 2, 2025approval331d agoMIRTAZAPINE — FDA approvalmirtazapine ODT

    Sponsor: ANNORA PHARMA. Form: TABLET. Route: ORAL

    full page →mirtazapine ODT →fda approvals ↗
    ›Oct 2, 2025approval331d agoOLANZAPINE — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

    Sponsor: CHARTWELL MOLECULAR. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →fda approvals ↗
    ›Oct 2, 2025approval331d agoOLANZAPINE — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

    Sponsor: CHARTWELL MOLECULAR. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →fda approvals ↗
    ›Oct 2, 2025approval331d agoETRAVIRINE — FDA approvalETRAVIRINE

    Sponsor: BIONPHARMA. Form: TABLET. Route: ORAL

    full page →ETRAVIRINE →fda approvals ↗
    ›Oct 3, 2025approval330d agoDEFLAZACORT — FDA approvalDEFLAZACORT

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

    full page →DEFLAZACORT →fda approvals ↗
    ›Oct 3, 2025approval330d agoDOVONEX (CALCIPOTRIENE) — FDA approvalcalcipotriene

    Sponsor: LEO PHARMA AS. Form: CREAM. Route: TOPICAL

    full page →calcipotriene →fda approvals ↗
    ›Oct 3, 2025approval330d agoNAPROXEN — FDA approvalNAPROXEN

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

    full page →NAPROXEN →fda approvals ↗
    ›Oct 3, 2025approval330d agoCLOMIPHENE CITRATE — FDA approvalCLOMIPHENE CITRATE

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

    full page →CLOMIPHENE CITRATE →fda approvals ↗
    ›Oct 3, 2025approval330d agoDOVONEX (CALCIPOTRIENE) — FDA approvalcalcipotriene

    Sponsor: LEO PHARMA AS. Form: OINTMENT. Route: TOPICAL

    full page →calcipotriene →fda approvals ↗
    ›Oct 3, 2025approval330d agoXELODA (CAPECITABINE) — FDA approvalArmas Pharmaceuticals Inc

    Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 3, 2025approval330d agoOMEPRAZOLE — FDA approvalomeprazole DR

    Sponsor: DEXCEL PHARMA. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →omeprazole DR →fda approvals ↗
    ›Oct 3, 2025approval330d agoDOCOSANOL — FDA approvalPL Developments Copiague LLC

    Sponsor: DR REDDYS. Form: CREAM. Route: TOPICAL

    full page →fda approvals ↗
    ›Oct 3, 2025approval330d agoAXTLE (PEMETREXED DIPOTASSIUM) — FDA approvalAXTLE

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

    full page →AXTLE →fda approvals ↗
    ›Oct 4, 2025approval329d agoZORYVE (ROFLUMILAST) — FDA approvalArcutis Biotherapeutics, Inc.

    Sponsor: ARCUTIS. Form: CREAM. Route: TOPICAL

    full page →fda approvals ↗

    Week of Oct 6, 2025

    33
    ›Oct 6, 2025approval327d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: APOTEX. Form: TABLET. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Oct 6, 2025approval
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    page 334 of 380
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    327d ago
    BUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Oct 6, 2025approval327d agoLIDOCAINE — FDA approvalSustained Therapeutics Inc

    Sponsor: ALKEM LABS LTD. Form: PATCH. Route: TOPICAL

    full page →fda approvals ↗
    ›Oct 6, 2025approval327d agoLITHIUM CARBONATE — FDA approvalCamber Pharmaceuticals Inc

    Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Oct 6, 2025approval327d agoBUSPIRONE HYDROCHLORIDE — FDA approvalBUSPIRONE HYDROCHLORIDE

    Sponsor: RISING. Form: TABLET. Route: ORAL

    full page →BUSPIRONE HYDROCHLORIDE →fda approvals ↗
    ›Oct 6, 2025approval327d agoSALONPAS (MENTHOL) — FDA approvalHisamitsu America Inc

    Sponsor: HISAMITSU PHARM CO. Form: PATCH. Route: TOPICAL

    full page →fda approvals ↗
    ›Oct 6, 2025approval327d agoLITHIUM CARBONATE — FDA approvalCamber Pharmaceuticals Inc

    Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Oct 6, 2025approval327d agoOLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE) — FDA approvalamlodipine besylate

    Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL

    full page →amlodipine besylate →fda approvals ↗
    ›Oct 7, 2025approval326d agoJASCAYD (NERANDOMILAST) — FDA approvalnerandomilast

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

    full page →nerandomilast →fda approvals ↗
    ›Oct 7, 2025approval326d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

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

    full page →fda approvals ↗
    ›Oct 7, 2025approval326d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

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

    full page →fda approvals ↗
    ›Oct 7, 2025approval326d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

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

    full page →remdesivir →fda approvals ↗
    ›Oct 7, 2025approval326d agoEXEMESTANE — FDA approvalEXEMESTANE

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →EXEMESTANE →fda approvals ↗
    ›Oct 7, 2025approval326d agoMETHYLIN ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETHYLIN ER

    Sponsor: SPECGX LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →METHYLIN ER →fda approvals ↗
    ›Oct 7, 2025approval326d agoLAMOTRIGINE — FDA approvalTorrent Pharma Inc

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

    full page →fda approvals ↗
    ›Oct 7, 2025approval326d agoFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE) — FDA approvalfexofenadine hydrochloride

    Sponsor: L PERRIGO CO. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fexofenadine hydrochloride →fda approvals ↗
    ›Oct 7, 2025approval326d agoTOPIRAMATE — FDA approvaltopiramate ER

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

    full page →topiramate ER →fda approvals ↗
    ›Oct 7, 2025approval326d agoRIVAROXABAN — FDA approvalJohnson & Johnson Innovative Medicine

    Sponsor: TARO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 7, 2025approval326d agoLASIX ONYU (FUROSEMIDE) — FDA approvalFurosemide Sun

    Sponsor: SQ INNOVATION. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →Furosemide Sun →fda approvals ↗
    ›Oct 8, 2025approval325d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

    Sponsor: SANOFI AVENTIS US. Form: INJECTABLE. Route: INJECTION

    full page →RIFADIN →fda approvals ↗
    ›Oct 8, 2025approval325d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

    Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

    full page →RIFATER →fda approvals ↗
    ›Oct 8, 2025approval325d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

    Sponsor: SANOFI AVENTIS US. Form: CAPSULE. Route: ORAL

    full page →RIFADIN →fda approvals ↗
    ›Oct 8, 2025approval325d agoRYBREVANT (AMIVANTAMAB-VMJW) — FDA approvalamivantamab

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

    full page →amivantamab →fda approvals ↗
    ›Oct 8, 2025approval325d agoLIBTAYO (CEMIPLIMAB-RWLC) — FDA approvalcemiplimab

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

    full page →cemiplimab →fda approvals ↗
    ›Oct 8, 2025approval325d agoTRIAMCINOLONE ACETONIDE — FDA approvaltriamcinolone acetonide Rising

    Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

    full page →triamcinolone acetonide Rising →fda approvals ↗
    ›Oct 8, 2025approval325d agoLUPKYNIS (VOCLOSPORIN) — FDA approvalvoclosporin

    Sponsor: AURINIA. Form: CAPSULE. Route: ORAL

    full page →voclosporin →fda approvals ↗
    ›Oct 8, 2025approval325d agoORGOVYX (RELUGOLIX) — FDA approvalrelugolix

    Sponsor: SUMITOMO PHARMA AM. Form: TABLET. Route: ORAL

    full page →relugolix →fda approvals ↗
    ›Oct 9, 2025approval324d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

    Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

    full page →fda approvals ↗
    ›Oct 9, 2025approval324d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: UPSHER SMITH LABS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Oct 9, 2025approval324d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalHYDROMORPHONE HYDROCHLORIDE

    Sponsor: ASCENT PHARMS INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗
    ›Oct 9, 2025approval324d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IMPAX LABS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Oct 9, 2025approval324d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: TEVA PHARMS USA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Oct 9, 2025approval324d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: ANDA REPOSITORY. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    $GILD147.94-0.10%
    $TEVA37.84-0.22%
    $ARQT23.78-4.38%
    $TEVA37.84-0.22%
    $REGN813.63-0.14%
    $AUPH16.50-0.24%
    $PRGO14.48+2.84%