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29,098 catalysts · 9,636 approval · 5,000 device 510k · 4,728 grant · 2,603 8k filing · 2,000 device pma · 2,000 device recall

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  • approval9,636
  • device 510k5,000
  • grant4,728
  • 8k filing2,603
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • earnings311
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jul 31, 2017

    12
    ›Jul 31, 2017approval3290d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

    Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

    full page →nivolumab →fda approvals ↗
    ›Jul 31, 2017approval3290d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

    full page →fda approvals ↗
    ›Jul 31, 2017approval3290d agoKALYDECO (IVACAFTOR) — FDA approvalivacaftor

    Sponsor: VERTEX PHARMS INC. Form: GRANULE. Route: ORAL

    full page →ivacaftor →fda approvals ↗
    ›Jul 31, 2017approval3290d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

    Sponsor: RISING. Form: INJECTABLE. Route: INJECTION

    full page →ondansetron hydrochloride CR →fda approvals ↗
    ›Jul 31, 2017approval3290d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Jul 31, 2017approval3290d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

    Sponsor: TAKEDA PHARMS USA. Form: TABLET, CHEWABLE. Route: ORAL

    full page →fda approvals ↗
    ›Aug 1, 2017approval3289d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

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

    full page →dulaglutide →fda approvals ↗
    ›Aug 1, 2017approval3289d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

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

    full page →dulaglutide →fda approvals ↗
    ›Aug 2, 2017approval3288d agoJUXTAPID (LOMITAPIDE MESYLATE) — FDA approvalChiesi USA Inc

    Sponsor: CHIESI. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Aug 2, 2017approval3288d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

    Sponsor: PHARMACYCLICS LLC. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Aug 3, 2017approval3287d agoVYXEOS (CYTARABINE) — FDA approvalMeitheal Pharmaceuticals Inc

    Sponsor: JAZZ PHARMS THERAP. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Aug 3, 2017approval3287d agoQVAR REDIHALER (BECLOMETHASONE DIPROPIONATE) — FDA approvalSOLIGENIX, INC.

    Sponsor: NORTON WATERFORD. Form: AEROSOL, METERED. Route: INHALATION

    full page →fda approvals ↗

    Week of Aug 7, 2017

    12
    ›Aug 7, 2017approval3283d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Aug 8, 2017approval

    Week of Aug 14, 2017

    6
    ›Aug 14, 2017approval3276d agoBUTRANS (BUPRENORPHINE) — FDA approvalBUTRANS

    Sponsor: PURDUE PHARMA LP. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

    full page →BUTRANS →fda approvals ↗
    ›Aug 14, 2017approval

    Week of Aug 21, 2017

    20
    ›Aug 21, 2017approval3269d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

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

    full page →fda approvals ↗
    ›Aug 21, 2017approval
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    3282d ago
    DILTIAZEM HYDROCHLORIDE — FDA approvalZydus Therapeutics Inc

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

    full page →fda approvals ↗
    ›Aug 10, 2017approval3280d agoFENTANYL-75 (FENTANYL) — FDA approvalDifGen Pharmaceuticals LLC

    Sponsor: DIFGEN PHARMS. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

    full page →fda approvals ↗
    ›Aug 10, 2017approval3280d agoFENTANYL-75 (FENTANYL) — FDA approvalDifGen Pharmaceuticals LLC

    Sponsor: DIFGEN PHARMS. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

    full page →fda approvals ↗
    ›Aug 10, 2017approval3280d agoGLYXAMBI (EMPAGLIFLOZIN) — FDA approval(empagliflozin + linagliptin)

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

    full page →(empagliflozin + linagliptin) →fda approvals ↗
    ›Aug 10, 2017approval3280d agoGLYXAMBI (EMPAGLIFLOZIN) — FDA approval(empagliflozin + linagliptin)

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

    full page →(empagliflozin + linagliptin) →fda approvals ↗
    ›Aug 11, 2017approval3279d agoWELLBUTRIN SR (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Aug 11, 2017approval3279d agoWELLBUTRIN (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

    Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Aug 12, 2017approval3278d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

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

    full page →tedizolid phosphate →fda approvals ↗
    ›Aug 12, 2017approval3278d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

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

    full page →tedizolid phosphate →fda approvals ↗
    ›Aug 12, 2017approval3278d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

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

    full page →tedizolid phosphate →fda approvals ↗
    ›Aug 12, 2017approval3278d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

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

    full page →tedizolid phosphate →fda approvals ↗
    3276d ago
    METFORMIN HYDROCHLORIDE — FDA approvalCenter for Biomedical Research for Neurodegenetive Diseases

    Sponsor: GRANULES INDIA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Aug 14, 2017approval3276d agoMETFORMIN HYDROCHLORIDE — FDA approvalCenter for Biomedical Research for Neurodegenetive Diseases

    Sponsor: GRANULES INDIA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Aug 15, 2017approval3275d agoOPILL (NORGESTREL) — FDA approvalHRA Pharma LLC

    Sponsor: LABORATOIRE HRA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Aug 15, 2017approval3275d agoOPILL (NORGESTREL) — FDA approvalHRA Pharma LLC

    Sponsor: LABORATOIRE HRA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Aug 16, 2017approval3274d agoDEMEROL (MEPERIDINE HYDROCHLORIDE) — FDA approvalMEPERIDINE HYDROCHLORIDE

    Sponsor: QUAGEN. Form: TABLET. Route: ORAL

    full page →MEPERIDINE HYDROCHLORIDE →fda approvals ↗
    3269d ago
    TRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

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

    full page →fda approvals ↗
    ›Aug 21, 2017approval3269d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

    full page →tramadol hydrochloride ER →fda approvals ↗
    ›Aug 21, 2017approval3269d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

    Sponsor: ACTAVIS ELIZABETH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →tramadol hydrochloride ER →fda approvals ↗
    ›Aug 21, 2017approval3269d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

    Sponsor: STRIDES PHARMA INTL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →tramadol hydrochloride ER →fda approvals ↗
    ›Aug 21, 2017approval3269d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

    Sponsor: STRIDES PHARMA INTL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →tramadol hydrochloride ER →fda approvals ↗
    ›Aug 22, 2017approval3268d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

    Sponsor: BAYER. Form: TABLET. Route: ORAL

    full page →NAPROXEN SODIUM →fda approvals ↗
    ›Aug 22, 2017approval3268d agoXELJANZ XR (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

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

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Aug 22, 2017approval3268d agoXELJANZ XR (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

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

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Aug 22, 2017approval3268d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

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

    full page →fda approvals ↗
    ›Aug 22, 2017approval3268d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

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

    full page →fda approvals ↗
    ›Aug 23, 2017approval3267d agoFLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) — FDA approvalGlaxoSmithKline LLC

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

    full page →fda approvals ↗
    ›Aug 24, 2017approval3266d agoAZITHROMYCIN — FDA approvalPFIZER INC

    Sponsor: CHARTWELL RX. Form: FOR SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Aug 24, 2017approval3266d agoAZITHROMYCIN — FDA approvalPFIZER INC

    Sponsor: CHARTWELL RX. Form: FOR SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Aug 25, 2017approval3265d agoDEXMEDETOMIDINE HYDROCHLORIDE — FDA approvalDEXMEDETOMIDINE HYDROCHLORIDE

    Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

    full page →DEXMEDETOMIDINE HYDROCHLORIDE →fda approvals ↗
    ›Aug 25, 2017approval3265d agoDEXMEDETOMIDINE HYDROCHLORIDE — FDA approvalDEXMEDETOMIDINE HYDROCHLORIDE

    Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

    full page →DEXMEDETOMIDINE HYDROCHLORIDE →fda approvals ↗
    ›Aug 25, 2017approval3265d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: CHARTWELL. Form: SOLUTION. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Aug 25, 2017approval3265d agoBUPROPION HYDROCHLORIDE — FDA approvalIpca Pharmaceuticals Inc

    Sponsor: PH HEALTH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Aug 25, 2017approval3265d agoBUPROPION HYDROCHLORIDE — FDA approvalIpca Pharmaceuticals Inc

    Sponsor: PH HEALTH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Aug 25, 2017approval3265d agoCYLTEZO (ADALIMUMAB-ADBM) — FDA approvalCYLTEZO

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

    full page →CYLTEZO →fda approvals ↗
    $BMY65.31+0.69%
    $SNGX
    $LLY1148.84-0.53%
    $LLY1148.84-0.53%
    $VERX12.91+2.46%
    $ABBV250.94-2.51%
    $VERX12.91+2.46%
    $PFE25.01+0.40%
    $PFE25.01+0.40%
    $PFE25.01+0.40%
    $PFE25.01+0.40%