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calendar

28,919 catalysts · 9,600 approval · 5,000 device 510k · 4,728 grant · 2,800 8k filing · 2,000 device pma · 2,000 device recall

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  • approval9,600
  • device 510k5,000
  • grant4,728
  • 8k filing2,800
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • earnings358
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jan 21, 2019

    8
    ›Jan 23, 2019approval2752d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

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

    full page →RIFADIN →fda approvals ↗
    ›Jan 24, 2019approval2751d agoSUBLIMAZE PRESERVATIVE FREE (FENTANYL CITRATE) — FDA approvalEffentora

    Sponsor: RISING. Form: INJECTABLE. Route: INJECTION

    full page →Effentora →fda approvals ↗
    ›Jan 24, 2019approval2751d agoFENTANYL CITRATE — FDA approvalEffentora

    Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

    full page →Effentora →fda approvals ↗
    ›Jan 25, 2019approval2750d agoDYNA-HEX 2 (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

    Sponsor: XTTRIUM. Form: SOLUTION. Route: TOPICAL

    full page →fda approvals ↗
    ›Jan 25, 2019approval2750d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

    Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Jan 25, 2019approval2750d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

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

    full page →fda approvals ↗
    ›Jan 25, 2019approval2750d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

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

    full page →fda approvals ↗
    ›Jan 25, 2019approval2750d agoTIZANIDINE HYDROCHLORIDE — FDA approvalRiconpharma LLC

    Sponsor: ALKEM LABS LTD. Form: TABLET. Route: ORAL

    full page →fda approvals ↗

    Week of Jan 28, 2019

    15
    ›Jan 28, 2019approval2747d agoOMEPRAZOLE — FDA approvalomeprazole DR

    Sponsor: DEXCEL. Form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE. Route: ORAL

    full page →omeprazole DR →fda approvals ↗
    ›Jan 28, 2019approval

    Week of Feb 4, 2019

    7
    ›Feb 4, 2019approval2740d agoLABETALOL HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Feb 4, 2019approval

    Week of Feb 11, 2019

    3
    ›Feb 11, 2019approval2733d agoVANTAS (HISTRELIN ACETATE) — FDA approvalEndo Pharmaceuticals Inc

    Sponsor: ENDO OPERATIONS. Form: IMPLANT. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Feb 14, 2019approval

    Week of Feb 18, 2019

    13
    ›Feb 20, 2019approval2724d agoNAPROXEN SODIUM — FDA approvalNAPROXEN SODIUM

    Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL

    full page →NAPROXEN SODIUM →fda approvals ↗
    ›Feb 21, 2019approval

    Week of Feb 25, 2019

    4
    ›Feb 27, 2019approval2717d agoSOLIQUA 100/33 (INSULIN GLARGINE) — FDA approvalToujeo LA

    Sponsor: SANOFI-AVENTIS US. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →Toujeo LA →fda approvals ↗
    ›Feb 27, 2019approval
    ← prev
    page 23 of 579
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    2747d ago
    ALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

    Sponsor: BAYER. Form: TABLET. Route: ORAL

    full page →NAPROXEN SODIUM →fda approvals ↗
    ›Jan 28, 2019approval2747d agoPREZCOBIX (COBICISTAT) — FDA approvalGILEAD SCIENCES, INC.

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

    full page →fda approvals ↗
    ›Jan 28, 2019approval2747d agoDIGOXIN — FDA approvalDIGOXIN

    Sponsor: RISING. Form: TABLET. Route: ORAL

    full page →DIGOXIN →fda approvals ↗
    ›Jan 29, 2019approval2746d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

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

    full page →fda approvals ↗
    ›Jan 29, 2019approval2746d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

    Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Jan 29, 2019approval2746d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

    Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Jan 29, 2019approval2746d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

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

    full page →guselkumab →fda approvals ↗
    ›Jan 31, 2019approval2744d agoSALONPAS (MENTHOL) — FDA approvalHisamitsu America Inc

    Sponsor: HISAMITSU PHARM CO. Form: PATCH. Route: TOPICAL

    full page →fda approvals ↗
    ›Feb 1, 2019approval2743d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗
    ›Feb 1, 2019approval2743d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Feb 1, 2019approval2743d agoXULTOPHY 100/3.6 (INSULIN DEGLUDEC) — FDA approvalNovo Nordisk Inc

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Feb 1, 2019approval2743d agoXULTOPHY 100/3.6 (INSULIN DEGLUDEC) — FDA approvalNovo Nordisk Inc

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Feb 2, 2019approval2742d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

    full page →ALDACTAZIDE →fda approvals ↗
    ›Feb 2, 2019approval2742d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

    full page →ALDACTAZIDE →fda approvals ↗
    2740d ago
    ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

    full page →fda approvals ↗
    ›Feb 4, 2019approval2740d agoANTARA (MICRONIZED) (FENOFIBRATE) — FDA approvalFENOFIBRATE

    Sponsor: LUPIN. Form: CAPSULE. Route: ORAL

    full page →FENOFIBRATE →fda approvals ↗
    ›Feb 5, 2019approval2739d agoDYANAVEL XR (AMPHETAMINE) — FDA approvalamfetamine ER

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

    full page →amfetamine ER →fda approvals ↗
    ›Feb 6, 2019approval2738d agoCABLIVI (CAPLACIZUMAB-YHDP) — FDA approvalGenzyme Corp

    Sponsor: ABLYNX NV. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 6, 2019approval2738d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

    Sponsor: RISING. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

    full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 7, 2019approval2737d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: ALKEM LABS LTD. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    2730d ago
    ENBREL (ETANERCEPT) — FDA approvalAMGEN INC

    Sponsor: IMMUNEX. Form: SYRINGE

    full page →fda approvals ↗
    ›Feb 15, 2019approval2729d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    2723d ago
    DEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

    Sponsor: ABBVIE. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

    full page →divalproex sodium DR →fda approvals ↗
    ›Feb 21, 2019approval2723d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

    full page →divalproex sodium DR →fda approvals ↗
    ›Feb 21, 2019approval2723d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

    full page →divalproex sodium DR →fda approvals ↗
    ›Feb 21, 2019approval2723d agoQUDEXY XR (TOPIRAMATE) — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

    Sponsor: UPSHER SMITH LABS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Feb 21, 2019approval2723d agoTROKENDI XR (TOPIRAMATE) — FDA approvalSUPERNUS PHARMACEUTICALS, INC.

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

    full page →fda approvals ↗
    ›Feb 21, 2019approval2723d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

    full page →POSACONAZOLE →fda approvals ↗
    ›Feb 21, 2019approval2723d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

    Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Feb 21, 2019approval2723d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

    Sponsor: MERCK SHARP DOHME. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →POSACONAZOLE →fda approvals ↗
    ›Feb 22, 2019approval2722d agoMALARONE PEDIATRIC (ATOVAQUONE) — FDA approvalatovaquone

    Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

    full page →atovaquone →fda approvals ↗
    ›Feb 22, 2019approval2722d agoMEPRON (ATOVAQUONE) — FDA approvalatovaquone

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

    full page →atovaquone →fda approvals ↗
    ›Feb 22, 2019approval2722d agoMETFORMIN HYDROCHLORIDE — FDA approvalCenter for Biomedical Research for Neurodegenetive Diseases

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

    full page →fda approvals ↗
    ›Feb 22, 2019approval2722d agoXELODA (CAPECITABINE) — FDA approvalArmas Pharmaceuticals Inc

    Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    2717d ago
    XULTOPHY 100/3.6 (INSULIN DEGLUDEC) — FDA approvalNovo Nordisk Inc

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Feb 27, 2019approval2717d agoXULTOPHY 100/3.6 (INSULIN DEGLUDEC) — FDA approvalNovo Nordisk Inc

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Feb 27, 2019approval2717d agoXULTOPHY 100/3.6 (INSULIN DEGLUDEC) — FDA approvalNovo Nordisk Inc

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    $CPIX7.9000+1.67%
    $ABBV246.01+0.91%
    $ABBV246.01+0.91%
    $GILD130.68-3.38%
    $BMY63.70-3.32%
    $AMRX18.62+0.76%
    $TRAW
    $AMGN412.48+5.76%
    $AMRX18.62+0.76%
    $ABBV246.01+0.91%
    $SUPN47.36+9.50%
    $ABBV246.01+0.91%
    $ABBV246.01+0.91%