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calendar

28,999 catalysts · 9,606 approval · 5,000 device 510k · 4,728 grant · 2,874 8k filing · 2,000 device pma · 2,000 device recall

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  • approval9,606
  • device 510k5,000
  • grant4,728
  • 8k filing2,874
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • earnings402
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Aug 5, 2019

    4
    ›Aug 7, 2019approval2557d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →ALDACTAZIDE →fda approvals ↗
    ›Aug 7, 2019approval2557d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →ALDACTAZIDE →fda approvals ↗
    ›Aug 8, 2019approval2556d agoXULTOPHY 100/3.6 (INSULIN DEGLUDEC) — FDA approvalNovo Nordisk Inc

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Aug 9, 2019approval2555d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

    Sponsor: UNICHEM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗

    Week of Aug 12, 2019

    12
    ›Aug 12, 2019approval2552d agoDOXIL (LIPOSOMAL) (DOXORUBICIN HYDROCHLORIDE) — FDA approvalDoxil

    Sponsor: BAXTER HLTHCARE CORP. Form: INJECTABLE, LIPOSOMAL. Route: INJECTION

    full page →Doxil →fda approvals ↗
    ›Aug 14, 2019approval

    Week of Aug 19, 2019

    4
    ›Aug 19, 2019approval2545d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

    Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

    full page →ALENDRONATE SODIUM →fda approvals ↗
    ›Aug 19, 2019approval

    Week of Aug 26, 2019

    9
    ›Aug 26, 2019approval2538d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

    Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Aug 26, 2019approval

    Week of Sep 2, 2019

    5
    ›Sep 4, 2019approval2529d agoHEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HEPARIN SODIUM) — FDA approvalHEPARIN SODIUM

    Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

    full page →HEPARIN SODIUM →fda approvals ↗
    ›Sep 6, 2019approval

    Week of Sep 9, 2019

    15
    ›Sep 9, 2019approval2524d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

    Sponsor: CUBIST PHARMS LLC. Form: TABLET. Route: ORAL

    full page →tedizolid phosphate →fda approvals ↗
    ›Sep 9, 2019approval

    Week of Sep 16, 2019

    1
    ›Sep 16, 2019approval2517d agoPANTOPRAZOLE SODIUM — FDA approvalPANTOPRAZOLE SODIUM

    Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

    full page →PANTOPRAZOLE SODIUM →fda approvals ↗
    ← prev
    page 28 of 580
    next →
    2550d ago
    BOSULIF (BOSUTINIB MONOHYDRATE) — FDA approvalAlembic Pharmaceuticals Inc

    Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Aug 14, 2019approval2550d agoWAKIX (PITOLISANT HYDROCHLORIDE) — FDA approvalpitolisant hydrochloride

    Sponsor: HARMONY. Form: TABLET. Route: ORAL

    full page →pitolisant hydrochloride →fda approvals ↗
    ›Aug 14, 2019approval2550d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

    Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Aug 14, 2019approval2550d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Aug 14, 2019approval2550d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

    Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Aug 14, 2019approval2550d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Aug 15, 2019approval2549d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Aug 16, 2019approval2548d agoINREBIC (FEDRATINIB HYDROCHLORIDE) — FDA approvalfedratinib

    Sponsor: BRISTOL-MYERS. Form: CAPSULE. Route: ORAL

    full page →fedratinib →fda approvals ↗
    ›Aug 16, 2019approval2548d agoFOSAMAX (ALENDRONATE SODIUM) — FDA approvalALENDRONATE SODIUM

    Sponsor: ORGANON. Form: TABLET. Route: ORAL

    full page →ALENDRONATE SODIUM →fda approvals ↗
    ›Aug 16, 2019approval2548d agoFOSAMAX PLUS D (ALENDRONATE SODIUM) — FDA approval(alendronate sodium + cholecalciferol)

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

    full page →(alendronate sodium + cholecalciferol) →fda approvals ↗
    ›Aug 16, 2019approval2548d agoRINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

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

    full page →upadacitinib tartrate ER →fda approvals ↗
    2545d ago
    FULVESTRANT — FDA approvalFULVESTRANT

    Sponsor: AVYXA HOLDINGS. Form: SOLUTION. Route: INTRAMUSCULAR

    full page →FULVESTRANT →fda approvals ↗
    ›Aug 23, 2019approval2541d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Aug 23, 2019approval2541d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

    Sponsor: ACTAVIS LABS FL INC. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    2538d ago
    MEDROL (METHYLPREDNISOLONE) — FDA approvalMEDROL

    Sponsor: PFIZER. Form: TABLET. Route: ORAL

    full page →MEDROL →fda approvals ↗
    ›Aug 27, 2019approval2537d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

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

    full page →RIFADIN →fda approvals ↗
    ›Aug 27, 2019approval2537d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

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

    full page →RIFATER →fda approvals ↗
    ›Aug 27, 2019approval2537d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

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

    full page →RIFADIN →fda approvals ↗
    ›Aug 28, 2019approval2536d agoORILISSA (ELAGOLIX SODIUM) — FDA approvalelagolix sodium

    Sponsor: ABBVIE. Form: TABLET. Route: ORAL

    full page →elagolix sodium →fda approvals ↗
    ›Aug 29, 2019approval2535d agoINBRIJA (LEVODOPA) — FDA approvallevodopa

    Sponsor: MERZ. Form: POWDER. Route: INHALATION

    full page →levodopa →fda approvals ↗
    ›Aug 30, 2019approval2534d agoXELJANZ XR (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

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

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Aug 30, 2019approval2534d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

    Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    2527d ago
    AUBAGIO (TERIFLUNOMIDE) — FDA approvalteriflunomide

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

    full page →teriflunomide →fda approvals ↗
    ›Sep 6, 2019approval2527d agoVIVITROL (NALTREXONE) — FDA approvalnaltrexone ER

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

    full page →naltrexone ER →fda approvals ↗
    ›Sep 6, 2019approval2527d agoMEROPENEM — FDA approvalMEROPENEM

    Sponsor: ACS DOBFAR SPA. Form: INJECTABLE. Route: INJECTION

    full page →MEROPENEM →fda approvals ↗
    ›Sep 6, 2019approval2527d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

    full page →certolizumab pegol →fda approvals ↗
    2524d ago
    SIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

    Sponsor: CUBIST PHARMS LLC. Form: POWDER. Route: INTRAVENOUS

    full page →tedizolid phosphate →fda approvals ↗
    ›Sep 9, 2019approval2524d agoPRAVASTATIN SODIUM — FDA approvalSenores Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Sep 9, 2019approval2524d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

    Sponsor: SUN PHARM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Sep 9, 2019approval2524d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: EPIC PHARMA LLC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Sep 10, 2019approval2523d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Sep 12, 2019approval2521d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

    Sponsor: PH HEALTH. Form: FOR SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Sep 12, 2019approval2521d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

    Sponsor: LUNDBECK PHARMS LLC. Form: TABLET. Route: ORAL

    full page →VIGABATRIN →fda approvals ↗
    ›Sep 12, 2019approval2521d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

    Sponsor: DR REDDYS. Form: FOR SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Sep 12, 2019approval2521d agoVIGABATRIN — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: AMNEAL PHARMS. Form: FOR SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Sep 12, 2019approval2521d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Sep 12, 2019approval2521d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: TEVA PHARMS USA. Form: FOR SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Sep 12, 2019approval2521d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

    Sponsor: LUNDBECK PHARMS LLC. Form: FOR SOLUTION. Route: ORAL

    full page →VIGABATRIN →fda approvals ↗
    ›Sep 12, 2019approval2521d agoVIGADRONE (VIGABATRIN) — FDA approvalVIGABATRIN

    Sponsor: AUCTA. Form: FOR SOLUTION. Route: ORAL

    full page →VIGABATRIN →fda approvals ↗
    ›Sep 13, 2019approval2520d agoCYLTEZO (ADALIMUMAB-ADBM) — FDA approvalCYLTEZO

    Sponsor: BOEHRINGER INGELHEIM. Form: INJECTABLE. Route: INJECTION

    full page →CYLTEZO →fda approvals ↗
    $AZN161.50+3.78%
    $HRMY38.24-1.39%
    $AMRX18.25-1.14%
    $ALKS49.53+1.10%
    $PFE25.81+1.57%
    $ABBV243.03-1.29%
    $OGN13.57+0.07%
    $OGN13.57+0.07%
    $PFE25.81+1.57%
    $ABBV243.03-1.29%
    $BMY63.81+0.28%