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calendar

4,537 catalysts · 3,350 8k filing · 2,401 grant · 2,136 approval · 1,479 device 510k · 1,105 device recall · 1,000 device adverse event

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type: approval×type: grant×from 2025-10-24×clear all
type
  • 8k filing3,350
  • grant2,401
  • approval2,136
  • device 510k1,479
  • device recall1,105
  • device adverse event1,000
device pma
977
  • earnings584
  • recall376
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Oct 20, 2025

    25
    ›Oct 24, 2025approval296d agoNEFFY (EPINEPHRINE) — FDA approvalInternational Medication Systems Ltd

    Sponsor: ARS PHARMS OPERATION. Form: SPRAY. Route: NASAL

    full page →fda approvals ↗
    ›Oct 24, 2025approval296d agoWINREVAIR (SOTATERCEPT-CSRK) — FDA approvalsotatercept

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

    full page →sotatercept →fda approvals ↗
    ›Oct 24, 2025approval296d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

    full page →tramadol hydrochloride ER →fda approvals ↗
    ›Oct 24, 2025approval296d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Oct 24, 2025approval296d agoTRAMADOL HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Oct 24, 2025approval296d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Oct 24, 2025approval296d agoATROPINE SULFATE — FDA approvalATROPINE SULFATE

    Sponsor: HIKMA. Form: SOLUTION. Route: INTRAVENOUS

    full page →ATROPINE SULFATE →fda approvals ↗
    ›Oct 24, 2025approval296d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

    Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL

    full page →ALDACTAZIDE →fda approvals ↗
    ›Oct 24, 2025approval296d agoANASTROZOLE — FDA approvalStason Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Oct 24, 2025approval296d agoLEFLUNOMIDE — FDA approvalLEFLUNOMIDE

    Sponsor: HERITAGE. Form: TABLET. Route: ORAL

    full page →LEFLUNOMIDE →fda approvals ↗
    ›Oct 24, 2025approval296d agoSYNJARDY XR (EMPAGLIFLOZIN) — FDA approval(empagliflozin + metformin hydrochloride ER)

    Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →(empagliflozin + metformin hydrochloride ER) →fda approvals ↗
    ›Oct 24, 2025approval296d agoLYNKUET (ELINZANETANT) — FDA approvalBayer USA LLC

    Sponsor: BAYER HLTHCARE. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Oct 24, 2025approval296d agoREVUFORJ (REVUMENIB CITRATE) — FDA approvalrevumenib citrate

    Sponsor: SYNDAX. Form: TABLET. Route: ORAL

    full page →revumenib citrate →fda approvals ↗
    ›Oct 24, 2025approval296d agoCOPIKTRA (DUVELISIB) — FDA approvalSecura Bio Inc

    Sponsor: SECURA. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Oct 24, 2025approval296d agoGLYXAMBI (EMPAGLIFLOZIN) — FDA approval(empagliflozin + linagliptin)

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

    full page →(empagliflozin + linagliptin) →fda approvals ↗
    ›Oct 24, 2025approval296d agoLETROZOLE — FDA approvalHikma Pharmaceuticals Plc

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

    full page →fda approvals ↗
    ›Oct 24, 2025approval296d agoANASTROZOLE — FDA approvalANASTROZOLE

    Sponsor: SANDOZ. Form: TABLET. Route: ORAL

    full page →ANASTROZOLE →fda approvals ↗
    ›Oct 24, 2025approval296d agoSYNJARDY (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

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

    full page →SYNJARDY →fda approvals ↗
    ›Oct 24, 2025approval296d agoTRIJARDY XR (EMPAGLIFLOZIN) — FDA approval(empagliflozin + linagliptin + metformin hydrochloride) ER

    Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →(empagliflozin + linagliptin + metformin hydrochloride) ER →fda approvals ↗
    ›Oct 24, 2025approval296d agoROCURONIUM BROMIDE — FDA approvalROCURONIUM BROMIDE

    Sponsor: B BRAUN MEDICAL. Form: SOLUTION. Route: INTRAVENOUS

    full page →ROCURONIUM BROMIDE →fda approvals ↗
    ›Oct 24, 2025approval296d agoJARDIANCE (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

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

    full page →SYNJARDY →fda approvals ↗
    ›Oct 24, 2025approval296d agoNEOSTIGMINE METHYLSULFATE — FDA approvalNEOSTIGMINE METHYLSULFATE

    Sponsor: AMPHASTAR PHARMS INC. Form: SOLUTION. Route: INTRAVENOUS

    full page →NEOSTIGMINE METHYLSULFATE →fda approvals ↗
    ›Oct 24, 2025approval296d agoRIVAROXABAN — FDA approvalRIVAROXABAN

    Sponsor: MSN. Form: TABLET. Route: ORAL

    full page →RIVAROXABAN →fda approvals ↗
    ›Oct 24, 2025approval296d agoANASTROZOLE — FDA approvalANASTROZOLE

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →ANASTROZOLE →fda approvals ↗
    ›Oct 25, 2025approval295d agoCARBON DIOXIDE, USP (CARBON DIOXIDE) — FDA approval

    Sponsor: ROBERTS OXYGEN CO INC. Form: GAS. Route: INHALATION

    full page →fda approvals ↗

    Week of Oct 27, 2025

    25
    ›Oct 27, 2025approval293d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

    Sponsor: PLIVA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 27, 2025approval
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    page 1 of 91
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    293d ago
    OPDIVO QVANTIG (NIVOLUMAB) — FDA approval(hyaluronidase (recombinant, human) + nivolumab)

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

    full page →(hyaluronidase (recombinant, human) + nivolumab) →fda approvals ↗
    ›Oct 27, 2025approval293d 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 ↗
    ›Oct 27, 2025approval293d agoLOMUSTINE — FDA approvalLOMUSTINE

    Sponsor: CARNEGIE. Form: CAPSULE. Route: ORAL

    full page →LOMUSTINE →fda approvals ↗
    ›Oct 27, 2025approval293d agoGLYCOPYRROLATE — FDA approvalFresenius Kabi USA LLC

    Sponsor: AJENAT PHARMS. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Oct 27, 2025approval293d agoCOLUMVI (GLOFITAMAB-GXBM) — FDA approvalglofitamab

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

    full page →glofitamab →fda approvals ↗
    ›Oct 27, 2025approval293d agoDUREZOL (DIFLUPREDNATE) — FDA approvalDIFLUPREDNATE

    Sponsor: SANDOZ. Form: EMULSION. Route: OPHTHALMIC

    full page →DIFLUPREDNATE →fda approvals ↗
    ›Oct 27, 2025approval293d agoPOTASSIUM CHLORIDE — FDA approvalTWi Pharmaceuticals Inc

    Sponsor: TWI PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Oct 27, 2025approval293d agoSEVELAMER CARBONATE — FDA approvalRenvela

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

    full page →Renvela →fda approvals ↗
    ›Oct 27, 2025approval293d agoASTEPRO ALLERGY (AZELASTINE HYDROCHLORIDE) — FDA approvalWallace Pharmaceuticals Inc

    Sponsor: BAYER HLTHCARE. Form: SPRAY, METERED. Route: NASAL

    full page →fda approvals ↗
    ›Oct 27, 2025approval293d agoKINERET (ANAKINRA) — FDA approvalSobi Inc

    Sponsor: BIOVITRUM AB. Form: VIAL. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Oct 28, 2025approval292d agoTICAGRELOR — FDA approvalTICAGRELOR

    Sponsor: APOTEX. Form: TABLET. Route: ORAL

    full page →TICAGRELOR →fda approvals ↗
    ›Oct 28, 2025approval292d agoTICAGRELOR — FDA approvalTICAGRELOR

    Sponsor: MSN. Form: TABLET. Route: ORAL

    full page →TICAGRELOR →fda approvals ↗
    ›Oct 28, 2025approval292d agoENLON-PLUS (ATROPINE SULFATE) — FDA approvalAccord Healthcare Inc

    Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Oct 28, 2025approval292d agoTRIUMEQ (ABACAVIR SULFATE) — FDA approvalViiV Healthcare Company

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

    full page →fda approvals ↗
    ›Oct 28, 2025approval292d agoENLON-PLUS (ATROPINE SULFATE) — FDA approvalAccord Healthcare Inc

    Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Oct 28, 2025approval292d agoEBGLYSS (LEBRIKIZUMAB-LBKZ) — FDA approvallebrikizumab

    Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION

    full page →lebrikizumab →fda approvals ↗
    ›Oct 28, 2025approval292d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

    full page →fda approvals ↗
    ›Oct 28, 2025approval292d agoDEXTROAMPHETAMINE SULFATE — FDA approvalDEXTROAMPHETAMINE SULFATE

    Sponsor: AZURITY. Form: TABLET. Route: ORAL

    full page →DEXTROAMPHETAMINE SULFATE →fda approvals ↗
    ›Oct 28, 2025approval292d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

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

    full page →fda approvals ↗
    ›Oct 28, 2025approval292d agoTICAGRELOR — FDA approvalSciegen Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Oct 28, 2025approval292d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

    Sponsor: TARO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 28, 2025approval292d agoNICARDIPINE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: QILU PHARM HAINAN. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Oct 28, 2025approval292d agoRENFLEXIS (INFLIXIMAB-ABDA) — FDA approvalinfliximab biosimilar

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

    full page →infliximab biosimilar →fda approvals ↗
    ›Oct 28, 2025approval292d agoTIVICAY PD (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

    Sponsor: VIIV HLTHCARE. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    $AMPH20.91+3.62%
    $SNDX19.84+3.98%
    $AMRX18.15+5.10%
    $LLY1180.16-2.25%
    $BMY63.83-1.27%
    $AMRX18.15+5.10%
    $BMY63.83-1.27%