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28,902 catalysts · 9,622 approval · 5,000 device 510k · 4,728 grant · 2,761 8k filing · 2,000 device pma · 2,000 device recall

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  • approval9,622
  • device 510k5,000
  • grant4,728
  • 8k filing2,761
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • earnings344
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Feb 4, 2019

    2
    ›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 ↗

    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

    9
    ›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

    Week of Mar 4, 2019

    7
    ›Mar 5, 2019approval2711d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

    Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

    full page →fda approvals ↗
    ›Mar 6, 2019approval

    Week of Mar 11, 2019

    5
    ›Mar 11, 2019approval2705d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

    Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

    full page →dupilumab →fda approvals ↗
    ›Mar 11, 2019approval

    Week of Mar 18, 2019

    3
    ›Mar 18, 2019approval2698d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

    full page →atezolizumab →fda approvals ↗
    ›Mar 20, 2019approval

    Week of Mar 25, 2019

    4
    ›Mar 27, 2019approval2689d agoTIZANIDINE HYDROCHLORIDE — FDA approvalRiconpharma LLC

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

    full page →fda approvals ↗
    ›Mar 28, 2019approval

    Week of Apr 1, 2019

    4
    ›Apr 2, 2019approval2683d agoBENAZEPRIL HYDROCHLORIDE — FDA approvalBENAZEPRIL HYDROCHLORIDE

    Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL

    full page →BENAZEPRIL HYDROCHLORIDE →fda approvals ↗
    ›Apr 2, 2019approval
    ← prev
    page 24 of 579
    next →
    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 ↗
    ›Feb 27, 2019approval2717d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

    full page →certolizumab pegol →fda approvals ↗
    ›Feb 28, 2019approval2716d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

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

    full page →Midol →fda approvals ↗
    ›Feb 28, 2019approval2716d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

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

    full page →RIFADIN →fda approvals ↗
    ›Feb 28, 2019approval2716d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

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

    full page →RIFATER →fda approvals ↗
    ›Feb 28, 2019approval2716d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

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

    full page →RIFADIN →fda approvals ↗
    2710d ago
    SIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

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

    full page →tedizolid phosphate →fda approvals ↗
    ›Mar 6, 2019approval2710d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

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

    full page →tedizolid phosphate →fda approvals ↗
    ›Mar 7, 2019approval2709d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗
    ›Mar 8, 2019approval2708d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Mar 8, 2019approval2708d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

    full page →atezolizumab →fda approvals ↗
    ›Mar 8, 2019approval2708d agoHALDOL (HALOPERIDOL DECANOATE) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    2705d ago
    NOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

    full page →POSACONAZOLE →fda approvals ↗
    ›Mar 11, 2019approval2705d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

    Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Mar 11, 2019approval2705d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

    full page →POSACONAZOLE →fda approvals ↗
    ›Mar 12, 2019approval2704d agoTIZANIDINE HYDROCHLORIDE — FDA approvalTIZANIDINE HYDROCHLORIDE

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

    full page →TIZANIDINE HYDROCHLORIDE →fda approvals ↗
    2696d ago
    LIBTAYO (CEMIPLIMAB-RWLC) — FDA approvalcemiplimab

    Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INTRAVENOUS

    full page →cemiplimab →fda approvals ↗
    ›Mar 21, 2019approval2695d agoRENFLEXIS (INFLIXIMAB-ABDA) — FDA approvalinfliximab biosimilar

    Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

    full page →infliximab biosimilar →fda approvals ↗
    2688d ago
    AMBRISENTAN — FDA approvalAMBRISENTAN

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

    full page →AMBRISENTAN →fda approvals ↗
    ›Mar 28, 2019approval2688d agoAMBRISENTAN — FDA approvalSigmapharm Laboratories LLC

    Sponsor: SUN PHARM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Mar 28, 2019approval2688d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

    full page →certolizumab pegol →fda approvals ↗
    2683d ago
    ADDYI (FLIBANSERIN) — FDA approvalSprout2 Inc

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

    full page →fda approvals ↗
    ›Apr 4, 2019approval2681d agoBUSULFAN — FDA approvalWoodward Pharma Services LLC

    Sponsor: ACTAVIS. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Apr 4, 2019approval2681d agoBUSULFAN — FDA approvalWoodward Pharma Services LLC

    Sponsor: ACTAVIS. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    $AMRX18.48-1.96%
    $REGN760.66+0.19%
    $ABBV243.80-0.53%
    $ABBV243.80-0.53%
    $BLNC
    $ABBV243.80-0.53%
    $BMY65.89+0.64%
    $AMGN390.02+2.94%
    $SUPN43.25-5.98%
    $IGC0.2670+0.41%
    $REGN760.66+0.19%