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28,964 catalysts · 9,438 approval · 5,000 device 510k · 4,728 grant · 2,667 8k filing · 2,000 device pma · 2,000 device recall

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  • approval9,438
  • device 510k5,000
  • grant4,728
  • 8k filing2,667
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • pdufa347
  • earnings320
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Mar 5, 2018

    18
    ›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗
    ›Mar 5, 2018approval3074d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗
    ›Mar 5, 2018approval3074d agoSUBLOCADE (BUPRENORPHINE) — FDA approvalbuprenorphine LA

    Sponsor: INDIVIOR. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS

    full page →buprenorphine LA →fda approvals ↗
    ›Mar 6, 2018approval3073d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

    full page →divalproex sodium DR →fda approvals ↗
    ›Mar 6, 2018approval3073d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

    full page →divalproex sodium DR →fda approvals ↗
    ›Mar 6, 2018approval3073d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

    full page →divalproex sodium DR →fda approvals ↗
    ›Mar 6, 2018approval3073d agoALDACTONE (SPIRONOLACTONE) — FDA approvalALDACTONE

    Sponsor: PFIZER. Form: TABLET. Route: ORAL

    full page →ALDACTONE →fda approvals ↗
    ›Mar 6, 2018approval3073d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

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

    full page →fda approvals ↗
    ›Mar 7, 2018approval3072d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

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

    full page →fda approvals ↗
    ›Mar 7, 2018approval3072d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

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

    full page →ondansetron hydrochloride CR →fda approvals ↗
    ›Mar 7, 2018approval3072d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

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

    full page →ondansetron hydrochloride CR →fda approvals ↗
    ›Mar 7, 2018approval3072d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

    Sponsor: RISING. Form: TABLET. Route: ORAL

    full page →ondansetron hydrochloride CR →fda approvals ↗
    ›Mar 7, 2018approval3072d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

    Sponsor: RISING. Form: TABLET. Route: ORAL

    full page →ondansetron hydrochloride CR →fda approvals ↗
    ›Mar 7, 2018approval3072d agoONDANSETRON — FDA approvalondansetron ODT

    Sponsor: AUROBINDO PHARMA. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →ondansetron ODT →fda approvals ↗
    ›Mar 7, 2018approval3072d agoONDANSETRON — FDA approvalSandoz Inc

    Sponsor: BARR. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →fda approvals ↗
    ›Mar 7, 2018approval3072d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

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

    full page →ondansetron hydrochloride CR →fda approvals ↗
    ›Mar 8, 2018approval3071d agoCINACALCET HYDROCHLORIDE — FDA approvalCINACALCET HYDROCHLORIDE

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

    full page →CINACALCET HYDROCHLORIDE →fda approvals ↗
    ›Mar 9, 2018approval3070d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Spexotras →fda approvals ↗

    Week of Mar 12, 2018

    5
    ›Mar 13, 2018approval3066d agoVIGABATRIN — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Mar 13, 2018approval

    Week of Mar 19, 2018

    12
    ›Mar 20, 2018approval3059d agoILUMYA (TILDRAKIZUMAB-ASMN) — FDA approvalSun Pharmaceutical Industries Ltd

    Sponsor: SUN PHARMA GLOBAL. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Mar 20, 2018approval

    Week of Mar 26, 2018

    11
    ›Mar 27, 2018approval3052d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

    Sponsor: BAYER. Form: TABLET. Route: ORAL

    full page →NAPROXEN SODIUM →fda approvals ↗
    ›Mar 27, 2018approval

    Week of Apr 2, 2018

    4
    ›Apr 3, 2018approval3045d agoAMLODIPINE BESYLATE — FDA approvalGraviti Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Apr 6, 2018approval
    ← prev
    page 4 of 580
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    3066d ago
    TECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

    full page →atezolizumab →fda approvals ↗
    ›Mar 15, 2018approval3064d agoCLEOCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) — FDA approvalclindamycin hydrochloride

    Sponsor: PFIZER. Form: CAPSULE. Route: ORAL

    full page →clindamycin hydrochloride →fda approvals ↗
    ›Mar 15, 2018approval3064d agoAMJEVITA (ADALIMUMAB-ATTO) — FDA approvalAMJEVITA

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

    full page →AMJEVITA →fda approvals ↗
    ›Mar 16, 2018approval3063d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

    full page →certolizumab pegol →fda approvals ↗
    3059d ago
    TEGRETOL-XR (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

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

    full page →carbamazepine ER →fda approvals ↗
    ›Mar 20, 2018approval3059d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Mar 20, 2018approval3059d agoTEGRETOL (CARBAMAZEPINE) — FDA approvalcarbamazepine ER

    Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Mar 20, 2018approval3059d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

    full page →certolizumab pegol →fda approvals ↗
    ›Mar 21, 2018approval3058d agoNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (ETHINYL ESTRADIOL) — FDA approvalNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

    Sponsor: APOTEX. Form: TABLET. Route: ORAL

    full page →NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE →fda approvals ↗
    ›Mar 21, 2018approval3058d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Mar 22, 2018approval3057d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

    full page →tocilizumab →fda approvals ↗
    ›Mar 22, 2018approval3057d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

    full page →tocilizumab →fda approvals ↗
    ›Mar 22, 2018approval3057d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

    Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

    full page →OXCARBAZEPINE →fda approvals ↗
    ›Mar 22, 2018approval3057d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →OXCARBAZEPINE →fda approvals ↗
    ›Mar 23, 2018approval3056d agoQSYMIA (PHENTERMINE HYDROCHLORIDE) — FDA approval(phentermine hydrochloride + topiramate) ER

    Sponsor: VIVUS LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →(phentermine hydrochloride + topiramate) ER →fda approvals ↗
    3052d ago
    ZYPREXA ZYDIS (OLANZAPINE) — FDA approvalDR REDDYS LABORATORIES LTD

    Sponsor: CHEPLAPHARM. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →fda approvals ↗
    ›Mar 27, 2018approval3052d agoZYPREXA RELPREVV (OLANZAPINE PAMOATE) — FDA approvalCHEPLAPHARM Arzneimittel GmbH

    Sponsor: CHEPLAPHARM. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›Mar 27, 2018approval3052d agoZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

    Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Mar 27, 2018approval3052d agoZYPREXA (OLANZAPINE) — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

    Sponsor: CHEPLAPHARM. Form: POWDER. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›Mar 28, 2018approval3051d agoSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) — FDA approvalmethylprednisolone sodium succinate

    Sponsor: PHARMACIA AND UPJOHN. Form: INJECTABLE. Route: INJECTION

    full page →methylprednisolone sodium succinate →fda approvals ↗
    ›Mar 29, 2018approval3050d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

    Sponsor: BAYER. Form: TABLET. Route: ORAL

    full page →NAPROXEN SODIUM →fda approvals ↗
    ›Mar 29, 2018approval3050d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

    Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

    full page →blinatumomab →fda approvals ↗
    ›Mar 30, 2018approval3049d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

    full page →METHADONE HYDROCHLORIDE →fda approvals ↗
    ›Mar 30, 2018approval3049d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Mar 30, 2018approval3049d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    3042d ago
    IBANDRONATE SODIUM — FDA approvalDR REDDYS LABORATORIES LTD

    Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Apr 6, 2018approval3042d agoIBANDRONATE SODIUM — FDA approvalDR REDDYS LABORATORIES LTD

    Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Apr 6, 2018approval3042d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    $BMY65.47+0.24%
    $BMY65.47+0.24%
    $NVS153.67-1.59%
    $AMRX18.85+2.89%
    $PFE25.03+0.08%
    $RDHL0.7390+6.64%
    $ABBV245.10-2.33%
    $ABBV245.10-2.33%
    $INDV40.10-2.17%
    $ABBV245.10-2.33%
    $PFE25.03+0.08%
    $AMGN378.87-1.63%
    $NVS153.67-1.59%
    $NVS153.67-1.59%
    $NVS153.67-1.59%
    $IGC0.2670+0.41%
    $NVS153.67-1.59%
    $NVS153.67-1.59%
    $RDY12.07+1.86%
    $TEVA34.46-1.57%
    $TEVA34.46-1.57%
    $AMGN378.87-1.63%
    $IGC0.2670+0.41%
    $RDY12.07+1.86%
    $RDY12.07+1.86%