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calendar

19,572 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

    no tagged catalysts yet

    Week of Dec 8, 2025

    17
    ›Dec 12, 2025approval261d agoADBRY (TRALOKINUMAB) — FDA approvaltralokinumab

    Sponsor: LEO PHARMA AS. Form: INJECTABLE. Route: INJECTION

    full page →tralokinumab →fda approvals ↗
    ›Dec 12, 2025approval261d agoROMVIMZA (VIMSELTINIB) — FDA approvalDeciphera Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Dec 12, 2025approval261d agoSTEQEYMA (USTEKINUMAB-STBA) — FDA approvalSTEQEYMA

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

    full page →STEQEYMA →fda approvals ↗
    ›Dec 12, 2025approval261d agoNUZOLVENCE (ZOLIFLODACIN) — FDA approvalEntasis Therapeutics Holdings Inc

    Sponsor: ENTASIS THERAP. Form: FOR SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Dec 12, 2025approval261d agoOCTREOTIDE ACETATE — FDA approvalChiasma Inc

    Sponsor: MYLAN LABS LTD. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Dec 12, 2025approval261d agoTERIPARATIDE — FDA approvalEB-613

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

    full page →EB-613 →fda approvals ↗
    ›Dec 12, 2025approval261d agoNISOLDIPINE — FDA approvalPrasco LLC

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

    full page →fda approvals ↗
    ›Dec 12, 2025approval261d agoLEROCHOL (LERODALCIBEP-LIGA) — FDA approvallerodalcibep

    Sponsor: LIB THERAPEUTICS, INC.. Form: INJECTABLE. Route: INJECTION

    full page →lerodalcibep →fda approvals ↗
    ›Dec 12, 2025approval261d agoDEPO-SUBQ PROVERA 104 (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

    Sponsor: PFIZER. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →medroxyprogesterone acetate →fda approvals ↗
    ›Dec 12, 2025approval261d agoILUMYA (TILDRAKIZUMAB-ASMN) — FDA approvalSun Pharmaceutical Industries Ltd

    Sponsor: SUN PHARMA GLOBAL. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Dec 12, 2025approval261d agoDEFLAZACORT — FDA approvalDEFLAZACORT

    Sponsor: AMNEAL. Form: TABLET. Route: ORAL

    full page →DEFLAZACORT →fda approvals ↗
    ›Dec 12, 2025approval261d agoCARDAMYST (ETRIPAMIL) — FDA approvalMilestone Pharmaceuticals Inc.

    Sponsor: MILESTONE PHARMS USA. Form: SPRAY. Route: NASAL

    full page →fda approvals ↗
    ›Dec 12, 2025approval261d agoDEPO-PROVERA (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

    Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

    full page →medroxyprogesterone acetate →fda approvals ↗
    ›Dec 12, 2025approval261d agoAKEEGA (ABIRATERONE ACETATE) — FDA approval(abiraterone acetate + niraparib)

    Sponsor: JANSSEN BIOTECH. Form: TABLET. Route: ORAL

    full page →(abiraterone acetate + niraparib) →fda approvals ↗
    ›Dec 12, 2025approval261d agoROLVEDON (EFLAPEGRASTIM-XNST) — FDA approvalSpectrum Pharmaceuticals Inc

    Sponsor: SPECTRUM PHARMS. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Dec 13, 2025approval260d agoADDYI (FLIBANSERIN) — FDA approvalSprout2 Inc

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

    full page →fda approvals ↗
    ›Dec 14, 2025approval259d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗

    Week of Dec 15, 2025

    33
    ›Dec 15, 2025approval258d agoLEQEMBI (LECANEMAB-IRMB) — FDA approvallecanemab

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

    full page →lecanemab →fda approvals ↗
    ›Dec 15, 2025approval
    ← prev
    page 347 of 392
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    258d ago
    LEQEMBI (LECANEMAB-IRMB) — FDA approvallecanemab

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

    full page →lecanemab →fda approvals ↗
    ›Dec 15, 2025approval258d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

    Sponsor: PHARMOBEDIENT. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    ›Dec 15, 2025approval258d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 15, 2025approval258d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 15, 2025approval258d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAurobindo Pharma Ltd

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

    full page →fda approvals ↗
    ›Dec 15, 2025approval258d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Dec 15, 2025approval258d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalLupin Ltd

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

    full page →fda approvals ↗
    ›Dec 15, 2025approval258d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 15, 2025approval258d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAurobindo Pharma Ltd

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

    full page →fda approvals ↗
    ›Dec 15, 2025approval258d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: RISING. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 15, 2025approval258d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalLupin Ltd

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

    full page →fda approvals ↗
    ›Dec 15, 2025approval258d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: PRINSTON INC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 15, 2025approval258d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

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

    full page →fda approvals ↗
    ›Dec 15, 2025approval258d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

    Sponsor: APOTEX. Form: TABLET. Route: ORAL

    full page →tramadol hydrochloride ER →fda approvals ↗
    ›Dec 15, 2025approval258d agoCLARISCAN (GADOTERATE MEGLUMINE) — FDA approvalCLARISCAN

    Sponsor: GE HEALTHCARE. Form: SOLUTION. Route: INTRAVENOUS

    full page →CLARISCAN →fda approvals ↗
    ›Dec 15, 2025approval258d agoCLARISCAN (GADOTERATE MEGLUMINE) — FDA approvalCLARISCAN

    Sponsor: GE HEALTHCARE. Form: SOLUTION. Route: INTRAVENOUS

    full page →CLARISCAN →fda approvals ↗
    ›Dec 15, 2025approval258d agoCLARISCAN (GADOTERATE MEGLUMINE) — FDA approvalCLARISCAN

    Sponsor: GE HEALTHCARE. Form: SOLUTION. Route: INTRAVENOUS

    full page →CLARISCAN →fda approvals ↗
    ›Dec 15, 2025approval258d agoCLARISCAN (GADOTERATE MEGLUMINE) — FDA approvalCLARISCAN

    Sponsor: GE HEALTHCARE. Form: SOLUTION. Route: INTRAVENOUS

    full page →CLARISCAN →fda approvals ↗
    ›Dec 15, 2025approval258d agoNILOTINIB — FDA approvalNILOTINIB

    Sponsor: TORRENT. Form: CAPSULE

    full page →NILOTINIB →fda approvals ↗
    ›Dec 15, 2025approval258d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Dec 15, 2025approval258d agoENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) — FDA approvaltrastuzumab deruxtecan

    Sponsor: DAIICHI SANKYO. Form: INJECTABLE. Route: INJECTION

    full page →trastuzumab deruxtecan →fda approvals ↗
    ›Dec 15, 2025approval258d agoENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) — FDA approvaltrastuzumab deruxtecan

    Sponsor: DAIICHI SANKYO. Form: INJECTABLE. Route: INJECTION

    full page →trastuzumab deruxtecan →fda approvals ↗
    ›Dec 15, 2025approval258d agoPEMETREXED DISODIUM — FDA approvalAlimta

    Sponsor: SANDOZ. Form: SOLUTION. Route: INTRAVENOUS

    full page →Alimta →fda approvals ↗
    ›Dec 15, 2025approval258d agoSULFAMETHOPRIM-DS (SULFAMETHOXAZOLE) — FDA approval

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

    full page →fda approvals ↗
    ›Dec 15, 2025approval258d agoSULFAMETHOPRIM-DS (SULFAMETHOXAZOLE) — FDA approval

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

    full page →fda approvals ↗
    ›Dec 16, 2025approval257d agoTIZANIDINE HYDROCHLORIDE — FDA approvalTIZANIDINE HYDROCHLORIDE

    Sponsor: APOTEX INC. Form: CAPSULE. Route: ORAL

    full page →TIZANIDINE HYDROCHLORIDE →fda approvals ↗
    ›Dec 16, 2025approval257d agoHYMPAVZI (MARSTACIMAB-HNCQ) — FDA approvalmarstacimab

    Sponsor: PFIZER INC. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →marstacimab →fda approvals ↗
    ›Dec 16, 2025approval257d agoEXDENSUR (DEPEMOKIMAB-ULAA) — FDA approvaldepemokimab

    Sponsor: GLAXOSMITHKLINE LLC. Form: INJECTION

    full page →depemokimab →fda approvals ↗
    ›Dec 16, 2025approval257d agoHYDROXYZINE HYDROCHLORIDE — FDA approvalHYDROXYZINE HYDROCHLORIDE

    Sponsor: NOVITIUM PHARMA. Form: SYRUP. Route: ORAL

    full page →HYDROXYZINE HYDROCHLORIDE →fda approvals ↗
    ›Dec 16, 2025approval257d agoFLUTICASONE PROPIONATE — FDA approvalFluticasone Propionate Glenmark

    Sponsor: AUROBINDO PHARMA LTD. Form: SPRAY, METERED. Route: NASAL

    full page →Fluticasone Propionate Glenmark →fda approvals ↗
    ›Dec 16, 2025approval257d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalAlembic Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Dec 16, 2025approval257d agoCARIPRAZINE HYDROCHLORIDE — FDA approvalCARIPRAZINE HYDROCHLORIDE

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

    full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗
    $MIST
    $IGC0.2670+0.41%
    $AMRX17.54-2.61%
    $PFE27.96-0.21%
    $PFE27.96-0.21%
    $TGTX55.72+1.25%
    $AMPH21.88-0.64%
    $AMRX17.54-2.61%
    $HCA417.82-0.36%
    $HCA417.82-0.36%
    $HCA417.82-0.36%
    $HCA417.82-0.36%
    $PFE27.96-0.21%