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calendar

28,950 catalysts · 9,622 approval · 5,000 device 510k · 4,728 grant · 2,809 8k filing · 2,000 device pma · 2,000 device recall

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  • approval9,622
  • device 510k5,000
  • grant4,728
  • 8k filing2,809
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • earnings364
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Sep 9, 2019

    15
    ›Sep 9, 2019approval2523d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

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

    full page →tedizolid phosphate →fda approvals ↗
    ›Sep 9, 2019approval2523d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

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

    full page →tedizolid phosphate →fda approvals ↗
    ›Sep 9, 2019approval2523d agoPRAVASTATIN SODIUM — FDA approvalSenores Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Sep 9, 2019approval2523d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

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

    full page →fda approvals ↗
    ›Sep 9, 2019approval2523d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Sep 10, 2019approval2522d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Sep 12, 2019approval2520d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

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

    full page →fda approvals ↗
    ›Sep 12, 2019approval2520d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

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

    full page →VIGABATRIN →fda approvals ↗
    ›Sep 12, 2019approval2520d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

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

    full page →fda approvals ↗
    ›Sep 12, 2019approval2520d agoVIGABATRIN — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Sep 12, 2019approval2520d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Sep 12, 2019approval2520d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Sep 12, 2019approval2520d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

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

    full page →VIGABATRIN →fda approvals ↗
    ›Sep 12, 2019approval2520d agoVIGADRONE (VIGABATRIN) — FDA approvalVIGABATRIN

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

    full page →VIGABATRIN →fda approvals ↗
    ›Sep 13, 2019approval2519d agoCYLTEZO (ADALIMUMAB-ADBM) — FDA approvalCYLTEZO

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

    full page →CYLTEZO →fda approvals ↗

    Week of Sep 16, 2019

    16
    ›Sep 16, 2019approval2516d agoPANTOPRAZOLE SODIUM — FDA approvalPANTOPRAZOLE SODIUM

    Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

    full page →PANTOPRAZOLE SODIUM →fda approvals ↗
    ›Sep 16, 2019approval

    Week of Sep 23, 2019

    16
    ›Sep 23, 2019approval2509d agoNARCAN (NALOXONE HYDROCHLORIDE) — FDA approvalEmergent Devices Inc

    Sponsor: EMERGENT. Form: SPRAY, METERED. Route: NASAL

    full page →fda approvals ↗
    ›Sep 23, 2019approval

    Week of Sep 30, 2019

    3
    ›Sep 30, 2019approval2502d agoDESIPRAMINE HYDROCHLORIDE — FDA approvalDESIPRAMINE HYDROCHLORIDE

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

    full page →DESIPRAMINE HYDROCHLORIDE →fda approvals ↗
    ›Oct 2, 2019approval
    ← prev
    page 29 of 579
    next →
    2516d ago
    PANTOPRAZOLE SODIUM — FDA approvalPANTOPRAZOLE SODIUM

    Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

    full page →PANTOPRAZOLE SODIUM →fda approvals ↗
    ›Sep 16, 2019approval2516d agoPANTOPRAZOLE SODIUM — FDA approvalPANTOPRAZOLE SODIUM

    Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

    full page →PANTOPRAZOLE SODIUM →fda approvals ↗
    ›Sep 16, 2019approval2516d agoPANTOPRAZOLE SODIUM — FDA approvalPANTOPRAZOLE SODIUM

    Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

    full page →PANTOPRAZOLE SODIUM →fda approvals ↗
    ›Sep 17, 2019approval2515d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

    Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

    full page →pembrolizumab →fda approvals ↗
    ›Sep 17, 2019approval2515d agoERLEADA (APALUTAMIDE) — FDA approvalapalutamide

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

    full page →apalutamide →fda approvals ↗
    ›Sep 17, 2019approval2515d agoOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalMicro Labs Ltd

    Sponsor: UMEDICA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Sep 18, 2019approval2514d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗
    ›Sep 19, 2019approval2513d agoFENOFIBRIC ACID (CHOLINE FENOFIBRATE) — FDA approvalcholine fenofibrate

    Sponsor: ALEMBIC. Form: CAPSULE, DELAYED RELEASE. Route: ORAL

    full page →choline fenofibrate →fda approvals ↗
    ›Sep 19, 2019approval2513d agoFENOFIBRIC ACID (CHOLINE FENOFIBRATE) — FDA approvalcholine fenofibrate

    Sponsor: ALEMBIC. Form: CAPSULE, DELAYED RELEASE. Route: ORAL

    full page →choline fenofibrate →fda approvals ↗
    ›Sep 19, 2019approval2513d agoFENOFIBRIC ACID (CHOLINE FENOFIBRATE) — FDA approvalcholine fenofibrate

    Sponsor: ALEMBIC. Form: CAPSULE, DELAYED RELEASE. Route: ORAL

    full page →choline fenofibrate →fda approvals ↗
    ›Sep 19, 2019approval2513d agoPIFELTRO (DORAVIRINE) — FDA approvaldoravirine

    Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL

    full page →doravirine →fda approvals ↗
    ›Sep 19, 2019approval2513d agoDELSTRIGO (DORAVIRINE) — FDA approval(doravirine + lamivudine + tenofovir disoproxil fumarate)

    Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL

    full page →(doravirine + lamivudine + tenofovir disoproxil fumarate) →fda approvals ↗
    ›Sep 19, 2019approval2513d agoHEPARIN SODIUM — FDA approvalHEPARIN SODIUM

    Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

    full page →HEPARIN SODIUM →fda approvals ↗
    ›Sep 19, 2019approval2513d agoHEPARIN SODIUM — FDA approvalHEPARIN SODIUM

    Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

    full page →HEPARIN SODIUM →fda approvals ↗
    ›Sep 20, 2019approval2512d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

    Sponsor: NOVO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    2509d ago
    BUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Sep 23, 2019approval2509d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Sep 23, 2019approval2509d agoMEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE (MEPERIDINE HYDROCHLORIDE) — FDA approvalHikma Pharmaceuticals Plc

    Sponsor: WEST-WARD PHARMS INT. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Sep 23, 2019approval2509d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: SPECGX LLC. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Sep 23, 2019approval2509d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Sep 23, 2019approval2509d agoVINCRISTINE SULFATE PFS (VINCRISTINE SULFATE) — FDA approvalVINCRISTINE SULFATE PFS

    Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

    full page →VINCRISTINE SULFATE PFS →fda approvals ↗
    ›Sep 24, 2019approval2508d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

    Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Sep 25, 2019approval2507d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Sep 25, 2019approval2507d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Sep 25, 2019approval2507d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Sep 25, 2019approval2507d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Sep 26, 2019approval2506d agoCOPIKTRA (DUVELISIB) — FDA approvalSecura Bio Inc

    Sponsor: SECURA. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Sep 27, 2019approval2505d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Sep 27, 2019approval2505d agoMEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE (MEPERIDINE HYDROCHLORIDE) — FDA approvalHikma Pharmaceuticals Plc

    Sponsor: INTL MEDICATION. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Sep 27, 2019approval2505d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

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

    full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗
    2500d ago
    METHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

    full page →METHADONE HYDROCHLORIDE →fda approvals ↗
    ›Oct 3, 2019approval2499d agoTRIAMCINOLONE ACETONIDE — FDA approvaltriamcinolone acetonide Rising

    Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

    full page →triamcinolone acetonide Rising →fda approvals ↗
    $AMRX18.46-0.11%
    $PFE25.81+1.57%
    $PFE25.81+1.57%
    $IGC0.2670+0.41%
    $MRK128.33+0.26%
    $MRK128.33+0.26%
    $BMY63.63-3.43%