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calendar

20,113 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
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  • recall1,126
  • device adverse event1,000
  • earnings585
  • therapy area

    no tagged catalysts yet

    Week of Sep 15, 2025

    17
    ›Sep 19, 2025approval345d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Sep 19, 2025approval345d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

    Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL

    full page →METHADONE HYDROCHLORIDE →fda approvals ↗
    ›Sep 19, 2025approval345d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

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

    full page →guselkumab →fda approvals ↗
    ›Sep 19, 2025approval345d agoLEUPROLIDE ACETATE — FDA approvalInvaGen Pharmaceuticals Inc

    Sponsor: SUN PHARM. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Sep 19, 2025approval345d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

    Sponsor: MEITHEAL. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗
    ›Sep 19, 2025approval345d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

    Sponsor: MEITHEAL. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗
    ›Sep 19, 2025approval345d agoLOPERAMIDE HYDROCHLORIDE — FDA approvalLOPERAMIDE HYDROCHLORIDE

    Sponsor: BIONPHARMA. Form: SOLUTION. Route: ORAL

    full page →LOPERAMIDE HYDROCHLORIDE →fda approvals ↗
    ›Sep 19, 2025approval345d agoAMBRISENTAN — FDA approvalAMBRISENTAN

    Sponsor: APOTEX. Form: TABLET. Route: ORAL

    full page →AMBRISENTAN →fda approvals ↗
    ›Sep 19, 2025approval345d agoFORZINITY (ELAMIPRETIDE HYDROCHLORIDE) — FDA approvalelamipretide hydrochloride

    Sponsor: STEALTH BIOTHERAPS. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →elamipretide hydrochloride →fda approvals ↗
    ›Sep 19, 2025approval345d agoDIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

    Sponsor: SUN PHARM INDS. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Sep 19, 2025approval345d agoDIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

    Sponsor: SUN PHARM INDS. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Sep 19, 2025approval345d agoGABAPENTIN — FDA approvalGABAPENTIN

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

    full page →GABAPENTIN →fda approvals ↗
    ›Sep 19, 2025approval345d agoPROGESTERONE — FDA approvalPROGESTERONE

    Sponsor: XIROMED. Form: INSERT. Route: VAGINAL

    full page →PROGESTERONE →fda approvals ↗
    ›Sep 19, 2025approval345d agoDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ATROPINE SULFATE) — FDA approvalANI PHARMACEUTICALS INC

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

    full page →fda approvals ↗
    ›Sep 19, 2025approval345d agoGABAPENTIN — FDA approvalSciegen Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Sep 19, 2025approval345d agoLOSARTAN POTASSIUM — FDA approvalGraviti Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Sep 19, 2025approval345d agoPROPOFOL — FDA approvalPROPOFOL

    Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

    full page →PROPOFOL →fda approvals ↗

    Week of Sep 22, 2025

    33
    ›Sep 22, 2025approval342d agoDOXYCYCLINE — FDA approvalPrasco LLC

    Sponsor: DR REDDYS. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Sep 22, 2025approval
    ← prev
    page 342 of 403
    next →
    342d ago
    IRON SUCROSE — FDA approvalsuccharated ferric oxide

    Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

    full page →succharated ferric oxide →fda approvals ↗
    ›Sep 22, 2025approval342d agoBIMATOPROST — FDA approvalLumigan

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

    full page →Lumigan →fda approvals ↗
    ›Sep 23, 2025approval341d agoCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Sep 23, 2025approval341d agoQUILLICHEW ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

    Sponsor: NEXTWAVE PHARMS. Form: TABLET, EXTENDED RELEASE, CHEWABLE. Route: ORAL

    full page →fda approvals ↗
    ›Sep 23, 2025approval341d agoQUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

    Sponsor: NEXTWAVE. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Sep 23, 2025approval341d agoCAMCEVI KIT (LEUPROLIDE MESYLATE) — FDA approvalForesee Pharmaceuticals Co Ltd

    Sponsor: ACCORD. Form: EMULSION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Sep 23, 2025approval341d agoCAPRELSA (VANDETANIB) — FDA approvalvandetanib

    Sponsor: GENZYME CORP. Form: TABLET. Route: ORAL

    full page →vandetanib →fda approvals ↗
    ›Sep 23, 2025approval341d agoLUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: ABBVIE ENDOCRINE INC. Form: POWDER. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›Sep 23, 2025approval341d agoLUPRON (LEUPROLIDE ACETATE) — FDA approvalInvaGen Pharmaceuticals Inc

    Sponsor: ABBVIE ENDOCRINE INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Sep 23, 2025approval341d agoFLAREX (FLUOROMETHOLONE ACETATE) — FDA approvalHARROW, INC.

    Sponsor: HARROW EYE. Form: SUSPENSION/DROPS. Route: OPHTHALMIC

    full page →fda approvals ↗
    ›Sep 23, 2025approval341d agoALVIMOPAN — FDA approvalALVIMOPAN

    Sponsor: HIKMA. Form: CAPSULE. Route: ORAL

    full page →ALVIMOPAN →fda approvals ↗
    ›Sep 23, 2025approval341d agoJORNAY PM (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

    Sponsor: IRONSHORE PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Sep 23, 2025approval341d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

    full page →certolizumab pegol →fda approvals ↗
    ›Sep 23, 2025approval341d agoTRIPTODUR KIT (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

    Sponsor: AZURITY. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

    full page →triptorelin pamoate ER →fda approvals ↗
    ›Sep 23, 2025approval341d agoDEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) — FDA approvalMallinckrodt LLC

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

    full page →fda approvals ↗
    ›Sep 23, 2025approval341d agoFOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) — FDA approvaldexmethylphenidate hydrochloride ER

    Sponsor: SANDOZ. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →dexmethylphenidate hydrochloride ER →fda approvals ↗
    ›Sep 23, 2025approval341d agoFENSOLVI KIT (LEUPROLIDE ACETATE) — FDA approvalLEUPROLIDE ACETATE

    Sponsor: TOLMAR. Form: POWDER. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗
    ›Sep 23, 2025approval341d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

    Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

    full page →triptorelin pamoate ER →fda approvals ↗
    ›Sep 23, 2025approval341d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

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

    full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗
    ›Sep 23, 2025approval341d agoLEUPROLIDE ACETATE — FDA approvalInvaGen Pharmaceuticals Inc

    Sponsor: SUN PHARM. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Sep 23, 2025approval341d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

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

    full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗
    ›Sep 23, 2025approval341d agoRELEXXII (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

    Sponsor: OSMOTICA PHARM US. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Sep 23, 2025approval341d agoALVIMOPAN — FDA approvalPar Pharmaceutical Inc

    Sponsor: WATSON LABS TEVA. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Sep 23, 2025approval341d agoZOLADEX (GOSERELIN ACETATE) — FDA approvalgoserelin LA

    Sponsor: TERSERA. Form: IMPLANT. Route: IMPLANTATION

    full page →goserelin LA →fda approvals ↗
    ›Sep 23, 2025approval341d agoPRIMIDONE — FDA approvalFrontida Biopharm Inc

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

    full page →fda approvals ↗
    ›Sep 23, 2025approval341d agoDAYTRANA (METHYLPHENIDATE) — FDA approvalNoven Pharmaceuticals Inc

    Sponsor: NOVEN PHARMS INC. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

    full page →fda approvals ↗
    ›Sep 23, 2025approval341d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

    Sponsor: AMNEAL. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗
    ›Sep 23, 2025approval341d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

    Sponsor: SANDOZ. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗
    ›Sep 23, 2025approval341d agoLABETALOL HYDROCHLORIDE — FDA approvalLABETALOL HYDROCHLORIDE

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

    full page →LABETALOL HYDROCHLORIDE →fda approvals ↗
    ›Sep 23, 2025approval341d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

    Sponsor: UBI. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗
    ›Sep 23, 2025approval341d agoMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETADATE CD

    Sponsor: AYTU BIOPHARMA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →METADATE CD →fda approvals ↗
    ›Sep 23, 2025approval341d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

    Sponsor: TAKEDA PHARMS USA. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    $ANIP72.83-0.93%
    $AMRX17.54-2.61%
    $AMRX17.54-2.61%
    $COLL26.44-3.89%
    $COLL26.44-3.89%
    $COLL26.44-3.89%
    $COLL26.44-3.89%
    $HROW37.27-3.30%
    $AMRX17.54-2.61%
    $AYTU2.2300-0.89%