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18,988 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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type: adcom×type: approval×clear all
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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
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    no tagged catalysts yet

    Week of Dec 15, 2025

    50
    ›Dec 16, 2025approval256d agoVYBRIQUE (SILDENAFIL CITRATE) — FDA approvalRevatio

    Sponsor: IBSA. Form: FILM. Route: ORAL

    full page →Revatio →fda approvals ↗
    ›Dec 16, 2025approval256d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

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

    full page →LOSARTAN POTASSIUM →fda approvals ↗
    ›Dec 16, 2025approval256d agoBECLOMETHASONE DIPROPIONATE — FDA approvalSOLIGENIX, INC.

    Sponsor: AMNEAL IRELAND LTD. Form: AEROSOL, METERED. Route: INHALATION

    full page →fda approvals ↗
    ›Dec 16, 2025approval256d agoLOSARTAN POTASSIUM — FDA approvalAlembic Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Dec 17, 2025approval255d agoWAINUA (AUTOINJECTOR) (EPLONTERSEN SODIUM) — FDA approvaleplontersen sodium

    Sponsor: ASTRAZENECA AB. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →eplontersen sodium →fda approvals ↗
    ›Dec 17, 2025approval255d agoZYNYZ (RETIFANLIMAB-DLWR) — FDA approvalretifanlimab

    Sponsor: INCYTE CORP. Form: INJECTABLE. Route: INTRAVENOUS

    full page →retifanlimab →fda approvals ↗
    ›Dec 17, 2025approval255d agoXeomin (incobotulinumtoxinA) — FDA approvalMerz Pharmaceuticals LLC

    Sponsor: MERZ PHARMS. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Dec 17, 2025approval255d agoGABAPENTIN — FDA approvalGABAPENTIN

    Sponsor: SANDOZ. Form: CAPSULE. Route: ORAL

    full page →GABAPENTIN →fda approvals ↗
    ›Dec 17, 2025approval255d agoGAZYVA (OBINUTUZUMAB) — FDA approvalobinutuzumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

    full page →obinutuzumab →fda approvals ↗
    ›Dec 17, 2025approval255d agoBORTEZOMIB — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: SHUANGCHENG. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

    full page →fda approvals ↗
    ›Dec 17, 2025approval255d agoLATANOPROST — FDA approvalXalatan

    Sponsor: MANKIND PHARMA. Form: SOLUTION/DROPS. Route: OPHTHALMIC

    full page →Xalatan →fda approvals ↗
    ›Dec 17, 2025approval255d agoVINCRISTINE SULFATE PFS (VINCRISTINE SULFATE) — FDA approvalVINCRISTINE SULFATE PFS

    Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

    full page →VINCRISTINE SULFATE PFS →fda approvals ↗
    ›Dec 17, 2025approval255d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: GRANULES. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 17, 2025approval255d agoORILISSA (ELAGOLIX SODIUM) — FDA approvalelagolix sodium

    Sponsor: ABBVIE. Form: TABLET. Route: ORAL

    full page →elagolix sodium →fda approvals ↗
    ›Dec 17, 2025approval255d agoRYBREVANT FASPRO (AMIVANTAMAB AND HYALURONIDASE-LPUJ) — FDA approval(amivantamab + hyaluronidase (human recombinant))

    Sponsor: JANSSEN BIOTECH. Form: INJECTION

    full page →(amivantamab + hyaluronidase (human recombinant)) →fda approvals ↗
    ›Dec 17, 2025approval255d agoRUBRACA (RUCAPARIB CAMSYLATE) — FDA approvalrucaparib camsylate

    Sponsor: PHARMAAND. Form: TABLET. Route: ORAL

    full page →rucaparib camsylate →fda approvals ↗
    ›Dec 17, 2025approval255d agoRUBRACA (RUCAPARIB CAMSYLATE) — FDA approvalrucaparib camsylate

    Sponsor: PHARMAAND. Form: TABLET. Route: ORAL

    full page →rucaparib camsylate →fda approvals ↗
    ›Dec 17, 2025approval255d agoCIPROFLOXACIN HYDROCHLORIDE — FDA approvalBayer HealthCare Pharmaceuticals Inc

    Sponsor: UNIQUE. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 17, 2025approval255d agoTESTOSTERONE — FDA approvalTransdermal Delivery Solutions Corp

    Sponsor: ENCUBE. Form: GEL. Route: TRANSDERMAL

    full page →fda approvals ↗
    ›Dec 17, 2025approval255d agoORIAHNN (COPACKAGED) (ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE) — FDA approvalORIAHNN (COPACKAGED)

    Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

    full page →ORIAHNN (COPACKAGED) →fda approvals ↗
    ›Dec 17, 2025approval255d agoABRILADA (ADALIMUMAB-AFZB) — FDA approvalABRILADA

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

    full page →ABRILADA →fda approvals ↗
    ›Dec 17, 2025approval255d agoTRAVOPROST — FDA approvalTRAVOPROST

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

    full page →TRAVOPROST →fda approvals ↗
    ›Dec 17, 2025approval255d agoADBRY (TRALOKINUMAB) — FDA approvaltralokinumab

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

    full page →tralokinumab →fda approvals ↗
    ›Dec 18, 2025approval254d agoCLOMIPHENE CITRATE — FDA approvalCLOMIPHENE CITRATE

    Sponsor: COSETTE. Form: TABLET. Route: ORAL

    full page →CLOMIPHENE CITRATE →fda approvals ↗
    ›Dec 18, 2025approval254d agoVRAYLAR (CARIPRAZINE HYDROCHLORIDE) — FDA approvalCARIPRAZINE HYDROCHLORIDE

    Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

    full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗
    ›Dec 18, 2025approval254d agoVRAYLAR (CARIPRAZINE HYDROCHLORIDE) — FDA approvalCARIPRAZINE HYDROCHLORIDE

    Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

    full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗
    ›Dec 18, 2025approval254d agoVRAYLAR (CARIPRAZINE HYDROCHLORIDE) — FDA approvalCARIPRAZINE HYDROCHLORIDE

    Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

    full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗
    ›Dec 18, 2025approval254d agoVRAYLAR (CARIPRAZINE HYDROCHLORIDE) — FDA approvalCARIPRAZINE HYDROCHLORIDE

    Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

    full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗
    ›Dec 18, 2025approval254d agoNITROGLYCERIN — FDA approvalNITROGLYCERIN

    Sponsor: SOLARIS PHARMA CORP. Form: OINTMENT. Route: INTRA-ANAL

    full page →NITROGLYCERIN →fda approvals ↗
    ›Dec 18, 2025approval254d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Dec 18, 2025approval254d agoNICARDIPINE HYDROCHLORIDE — FDA approvalNICARDIPINE HYDROCHLORIDE

    Sponsor: CHENGDU SHUODE. Form: INJECTABLE. Route: INJECTION

    full page →NICARDIPINE HYDROCHLORIDE →fda approvals ↗
    ›Dec 18, 2025approval254d agoNUFYMCO (RANIBIZUMAB-LEYK) — FDA approvalNUFYMCO

    Sponsor: FORMYCON AG. Form: INJECTION

    full page →NUFYMCO →fda approvals ↗
    ›Dec 18, 2025approval254d agoVARENICLINE TARTRATE — FDA approvalVARENICLINE TARTRATE

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

    full page →VARENICLINE TARTRATE →fda approvals ↗
    ›Dec 18, 2025approval254d agoTENOFOVIR DISOPROXIL FUMARATE — FDA approvalTENOFOVIR DISOPROXIL FUMARATE

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

    full page →TENOFOVIR DISOPROXIL FUMARATE →fda approvals ↗
    ›Dec 18, 2025approval254d agoHALOPERIDOL — FDA approvalCreekwood Pharmaceutical Inc

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

    full page →fda approvals ↗
    ›Dec 19, 2025approval253d agoMYQORZO (AFICAMTEN) — FDA approvalaficamten

    Sponsor: CYTOKINETICS. Form: TABLET. Route: ORAL

    full page →aficamten →fda approvals ↗
    ›Dec 19, 2025approval253d agoMOUNJARO (TIRZEPATIDE) — FDA approvalZEPBOUND

    Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →ZEPBOUND →fda approvals ↗
    ›Dec 19, 2025approval253d agoDECITABINE — FDA approvalDECITABINE

    Sponsor: RELIANCE LIFE SCI. Form: INJECTABLE. Route: INTRAVENOUS

    full page →DECITABINE →fda approvals ↗
    ›Dec 19, 2025approval253d agoLUNSUMIO (MOSUNETUZUMAB-AXGB) — FDA approvalmosunetuzumab

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

    full page →mosunetuzumab →fda approvals ↗
    ›Dec 19, 2025approval253d agoREZDIFFRA (RESMETIROM) — FDA approvalresmetirom

    Sponsor: MADRIGAL. Form: TABLET. Route: ORAL

    full page →resmetirom →fda approvals ↗
    ›Dec 19, 2025approval253d agoREZDIFFRA (RESMETIROM) — FDA approvalresmetirom

    Sponsor: MADRIGAL. Form: TABLET. Route: ORAL

    full page →resmetirom →fda approvals ↗
    ›Dec 19, 2025approval253d agoREZDIFFRA (RESMETIROM) — FDA approvalresmetirom

    Sponsor: MADRIGAL. Form: TABLET. Route: ORAL

    full page →resmetirom →fda approvals ↗
    ›Dec 19, 2025approval253d agoJASCAYD (NERANDOMILAST) — FDA approvalnerandomilast

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

    full page →nerandomilast →fda approvals ↗
    ›Dec 19, 2025approval253d agoBONCRESA (DENOSUMAB-MOBZ) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: AMNEAL PHARMS LLC. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Dec 19, 2025approval253d agoOZILTUS (DENOSUMAB-MOBZ) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: AMNEAL PHARMS LLC. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Dec 19, 2025approval253d agoFLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) — FDA approvalGlaxoSmithKline LLC

    Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

    full page →fda approvals ↗
    ›Dec 19, 2025approval253d agoBYLVAY (ODEVIXIBAT) — FDA approvalodevixibat

    Sponsor: IPSEN. Form: CAPSULE. Route: ORAL

    full page →odevixibat →fda approvals ↗
    ›Dec 19, 2025approval253d agoACCRUFER (FERRIC MALTOL) — FDA approvalferric maltol

    Sponsor: SHIELD TX. Form: CAPSULE. Route: ORAL

    full page →ferric maltol →fda approvals ↗
    ›Dec 19, 2025approval253d agoFLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) — FDA approvalParatek Pharmaceuticals Inc

    Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

    full page →fda approvals ↗
    ›Dec 19, 2025approval253d agoZINGO (LIDOCAINE HYDROCHLORIDE) — FDA approvalPowder Pharmaceuticals Inc

    Sponsor: POWDER PHARMS. Form: SYSTEM. Route: INTRADERMAL

    full page →fda approvals ↗
    ← prev
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    $PFE27.96-0.21%
    $AZN164.52-1.05%
    $ABBV255.48-1.03%
    $INCY124.37-2.64%
    $ABBV255.48-1.03%
    $AMRX17.54-2.61%
    $SNGX
    $ABBV255.48-1.03%
    $MDGL543.69+0.89%
    $CYTK72.09-7.46%
    $ABBV255.48-1.03%
    $MDGL543.69+0.89%
    $ABBV255.48-1.03%
    $ABBV255.48-1.03%
    $LLY1174.61-0.13%
    $MDGL543.69+0.89%
    $AMRX17.54-2.61%
    $AMRX17.54-2.61%