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calendar

29,196 catalysts · 9,600 approval · 5,000 device 510k · 4,728 grant · 2,701 8k filing · 2,000 device pma · 2,000 device recall

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  • approval9,600
  • device 510k5,000
  • grant4,728
  • 8k filing2,701
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • pdufa383
  • earnings325
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jun 18, 2018

    13
    ›Jun 19, 2018approval2969d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

    Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Jun 19, 2018approval2969d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›Jun 19, 2018approval2969d agoTOPAMAX SPRINKLE (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Jun 19, 2018approval2969d agoTOPAMAX (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Jun 19, 2018approval2969d agoPROMETHAZINE WITH CODEINE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

    Sponsor: PHARM ASSOC. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    ›Jun 19, 2018approval2969d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

    Sponsor: ACTAVIS MID ATLANTIC. Form: SYRUP. Route: ORAL

    full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
    ›Jun 19, 2018approval2969d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

    Sponsor: HIKMA. Form: SYRUP. Route: ORAL

    full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
    ›Jun 19, 2018approval2969d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

    full page →atezolizumab →fda approvals ↗
    ›Jun 21, 2018approval2967d agoVIGADRONE (VIGABATRIN) — FDA approvalVIGABATRIN

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

    full page →VIGABATRIN →fda approvals ↗
    ›Jun 21, 2018approval2967d agoULTIVA (REMIFENTANIL HYDROCHLORIDE) — FDA approvalremifentanil hydrochloride

    Sponsor: MYLAN INSTITUTIONAL. Form: INJECTABLE. Route: INJECTION

    full page →remifentanil hydrochloride →fda approvals ↗
    ›Jun 22, 2018approval2966d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Jun 22, 2018approval2966d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: AMNEAL PHARMS. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    ›Jun 22, 2018approval2966d agoPROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

    Sponsor: HIKMA. Form: SYRUP. Route: ORAL

    full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗

    Week of Jun 25, 2018

    29
    ›Jun 26, 2018approval2962d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

    Sponsor: COSETTE. Form: SYRUP. Route: ORAL

    full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
    ›Jun 26, 2018

    Week of Jul 2, 2018

    6
    ›Jul 2, 2018approval2956d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Jul 2, 2018approval

    Week of Jul 9, 2018

    2
    ›Jul 10, 2018approval2948d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗
    ›Jul 11, 2018approval
    ← prev
    page 10 of 584
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    approval
    2962d ago
    PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

    Sponsor: GENUS LIFESCIENCES. Form: SYRUP. Route: ORAL

    full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
    ›Jun 26, 2018approval2962d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

    full page →atezolizumab →fda approvals ↗
    ›Jun 27, 2018approval2961d agoBRAFTOVI (ENCORAFENIB) — FDA approvalencorafenib

    Sponsor: ARRAY BIOPHARMA INC. Form: CAPSULE. Route: ORAL

    full page →encorafenib →fda approvals ↗
    ›Jun 27, 2018approval2961d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Jun 27, 2018approval2961d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Jun 27, 2018approval2961d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Jun 27, 2018approval2961d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

    full page →LAMOTRIGINE →fda approvals ↗
    ›Jun 28, 2018approval2960d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

    Sponsor: PHARMOBEDIENT. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

    Sponsor: COSETTE. Form: SYRUP. Route: ORAL

    full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
    ›Jun 28, 2018approval2960d agoPROMETHAZINE WITH CODEINE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

    Sponsor: PHARM ASSOC. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

    Sponsor: ACTAVIS MID ATLANTIC. Form: SYRUP. Route: ORAL

    full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
    ›Jun 28, 2018approval2960d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

    Sponsor: CHARTWELL RX. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: AMNEAL PHARMS. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d agoPROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

    Sponsor: GENUS LIFESCIENCES. Form: SYRUP. Route: ORAL

    full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
    ›Jun 28, 2018approval2960d agoPROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

    Sponsor: GENUS LIFESCIENCES. Form: SYRUP. Route: ORAL

    full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
    ›Jun 28, 2018approval2960d agoHYCOFENIX (GUAIFENESIN) — FDA approvalMoberg Pharma AB

    Sponsor: CHARTWELL RX. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d agoPROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

    Sponsor: HIKMA. Form: SYRUP. Route: ORAL

    full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
    ›Jun 28, 2018approval2960d agoPROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: AMNEAL PHARMS. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d agoTRIACIN-C (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

    Sponsor: ANIMA. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

    Sponsor: HIKMA. Form: SYRUP. Route: ORAL

    full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
    ›Jun 28, 2018approval2960d agoFLOWTUSS (GUAIFENESIN) — FDA approvalMoberg Pharma AB

    Sponsor: CHARTWELL RX. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d agoPHENERGAN W/ CODEINE (CODEINE PHOSPHATE) — FDA approvalANI PHARMACEUTICALS INC

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

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d agoPROMETH VC W/ CODEINE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

    Sponsor: CHARTWELL RX. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d agoTUZISTRA XR (CHLORPHENIRAMINE POLISTIREX) — FDA approvalTUZISTRA XR

    Sponsor: TRIS PHARMA INC. Form: SUSPENSION, EXTENDED RELEASE. Route: ORAL

    full page →TUZISTRA XR →fda approvals ↗
    ›Jun 28, 2018approval2960d agoOBREDON (GUAIFENESIN) — FDA approvalMoberg Pharma AB

    Sponsor: SOVEREIGN PHARMS. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Jun 28, 2018approval2960d agoHYCODAN (HOMATROPINE METHYLBROMIDE) — FDA approval

    Sponsor: GENUS. Form: SYRUP. Route: ORAL

    full page →fda approvals ↗
    ›Jun 29, 2018approval2959d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

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

    full page →dulaglutide →fda approvals ↗
    ›Jun 29, 2018approval2959d agoYONDELIS (TRABECTEDIN) — FDA approvalJOHNSON & JOHNSON

    Sponsor: JANSSEN PRODS. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    2956d ago
    OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Jul 2, 2018approval2956d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

    full page →atezolizumab →fda approvals ↗
    ›Jul 3, 2018approval2955d agoXeomin (incobotulinumtoxinA) — FDA approvalMerz Pharmaceuticals LLC

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

    full page →fda approvals ↗
    ›Jul 5, 2018approval2953d agoROBINUL (GLYCOPYRROLATE) — FDA approvalGLYCOPYRROLATE

    Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

    full page →GLYCOPYRROLATE →fda approvals ↗
    ›Jul 6, 2018approval2952d agoVABOMERE (MEROPENEM) — FDA approvalHQ Speciality Pharma

    Sponsor: REMPEX. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    2947d ago
    DALFAMPRIDINE — FDA approvaldalfampridine ER

    Sponsor: ACCORD HLTHCARE. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →dalfampridine ER →fda approvals ↗
    $NVS153.16-0.33%
    $AMRX18.85+2.89%
    $AMRX18.85+2.89%
    $BMY65.79+0.49%
    $LLY1112.77-0.77%
    $TRAW
    $AMRX18.85+2.89%
    $AVBP31.23+5.36%
    $ANIP79.65-0.51%
    $JNJ253.79-0.24%
    $AMRX18.85+2.89%