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calendar

29,089 catalysts · 9,600 approval · 5,000 device 510k · 4,728 grant · 2,630 8k filing · 2,000 device pma · 2,000 device recall

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  • approval9,600
  • device 510k5,000
  • grant4,728
  • 8k filing2,630
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • pdufa347
  • earnings317
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Sep 18, 2017

    3
    ›Sep 22, 2017approval3238d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗
    ›Sep 22, 2017approval3238d agoTEMOZOLOMIDE — FDA approvalAreva Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Sep 22, 2017approval3238d agoTRAVATAN Z (TRAVOPROST) — FDA approvalTRAVOPROST

    Sponsor: SANDOZ. Form: SOLUTION/DROPS. Route: OPHTHALMIC

    full page →TRAVOPROST →fda approvals ↗

    Week of Sep 25, 2017

    9
    ›Sep 25, 2017approval3235d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: LANNETT CO INC. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Sep 25, 2017approval

    Week of Oct 2, 2017

    5
    ›Oct 5, 2017approval3225d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

    full page →divalproex sodium DR →fda approvals ↗
    ›Oct 5, 2017approval

    Week of Oct 9, 2017

    3
    ›Oct 13, 2017approval3217d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

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

    full page →fda approvals ↗
    ›Oct 13, 2017approval

    Week of Oct 16, 2017

    5
    ›Oct 17, 2017approval3213d agoHIBICLENS (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

    Sponsor: MOLNLYCKE HLTH. Form: SOLUTION. Route: TOPICAL

    full page →fda approvals ↗
    ›Oct 19, 2017approval

    Week of Oct 23, 2017

    7
    ›Oct 23, 2017approval3207d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

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

    full page →fda approvals ↗
    ›Oct 23, 2017approval

    Week of Oct 30, 2017

    10
    ›Oct 30, 2017approval3200d agoDOXYCYCLINE — FDA approvaldoxycycline ER

    Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

    full page →doxycycline ER →fda approvals ↗
    ›Oct 30, 2017approval

    Week of Nov 6, 2017

    6
    ›Nov 6, 2017approval3193d agoTELMISARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

    Sponsor: PRINSTON INC. Form: TABLET. Route: ORAL

    full page →ALDACTAZIDE →fda approvals ↗
    ›Nov 6, 2017approval

    Week of Nov 13, 2017

    2
    ›Nov 13, 2017approval3186d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

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

    full page →fda approvals ↗
    ›Nov 13, 2017approval
    ← prev
    page 3 of 582
    next →
    3235d ago
    NEOSTIGMINE METHYLSULFATE — FDA approvalNEOSTIGMINE METHYLSULFATE

    Sponsor: AMPHASTAR PHARMS INC. Form: SOLUTION. Route: INTRAVENOUS

    full page →NEOSTIGMINE METHYLSULFATE →fda approvals ↗
    ›Sep 28, 2017approval3232d agoSOLIQUA 100/33 (INSULIN GLARGINE) — FDA approvalToujeo LA

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

    full page →Toujeo LA →fda approvals ↗
    ›Sep 28, 2017approval3232d agoDOXYCYCLINE — FDA approvalZydus Therapeutics Inc

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

    full page →fda approvals ↗
    ›Sep 29, 2017approval3231d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

    full page →ALDACTAZIDE →fda approvals ↗
    ›Sep 29, 2017approval3231d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

    Sponsor: AMNEAL PHARMS NY. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Sep 29, 2017approval3231d agoAFREZZA (INSULIN RECOMBINANT HUMAN) — FDA approvalinsulin human

    Sponsor: MANNKIND. Form: POWDER. Route: INHALATION

    full page →insulin human →fda approvals ↗
    ›Sep 29, 2017approval3231d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Imatinib Mesylate Shilpa →fda approvals ↗
    ›Sep 29, 2017approval3231d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    3225d ago
    DEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

    full page →divalproex sodium DR →fda approvals ↗
    ›Oct 5, 2017approval3225d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

    full page →divalproex sodium DR →fda approvals ↗
    ›Oct 5, 2017approval3225d agoCOMETRIQ (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

    Sponsor: EXELIXIS. Form: CAPSULE. Route: ORAL

    full page →cabozantinib s-malate →fda approvals ↗
    ›Oct 6, 2017approval3224d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

    Sponsor: IMMUNEX. Form: SYRINGE

    full page →fda approvals ↗
    3217d ago
    BUTRANS (BUPRENORPHINE) — FDA approvalBUTRANS

    Sponsor: PURDUE PHARMA LP. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

    full page →BUTRANS →fda approvals ↗
    ›Oct 15, 2017approval3215d agoMEPRON (ATOVAQUONE) — FDA approvalatovaquone

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

    full page →atovaquone →fda approvals ↗
    3211d ago
    TYVASO (TREPROSTINIL) — FDA approvalUNITED THERAPEUTICS Corp

    Sponsor: UNITED THERAP. Form: SOLUTION. Route: INHALATION

    full page →fda approvals ↗
    ›Oct 20, 2017approval3210d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

    Sponsor: ACTELION. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 20, 2017approval3210d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

    Sponsor: ACTELION. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Oct 20, 2017approval3210d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

    Sponsor: PADAGIS US. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    3207d ago
    SABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

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

    full page →VIGABATRIN →fda approvals ↗
    ›Oct 23, 2017approval3207d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

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

    full page →VIGABATRIN →fda approvals ↗
    ›Oct 25, 2017approval3205d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

    Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL

    full page →ALDACTAZIDE →fda approvals ↗
    ›Oct 27, 2017approval3203d agoZOLEDRONIC ACID — FDA approvalNOVARTIS AG

    Sponsor: MYLAN LABS LTD. Form: INJECTABLE. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Oct 27, 2017approval3203d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Oct 27, 2017approval3203d agoFLUOROURACIL — FDA approvalEfudex

    Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

    full page →Efudex →fda approvals ↗
    3200d ago
    HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Oct 30, 2017approval3200d agoZEGERID OTC (OMEPRAZOLE) — FDA approvalCovis Pharmaceuticals Inc (Inactive)

    Sponsor: RILEY CONSUMER. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Oct 30, 2017approval3200d agoOMEPRAZOLE — FDA approvalomeprazole DR

    Sponsor: DEXCEL PHARMA. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →omeprazole DR →fda approvals ↗
    ›Oct 31, 2017approval3199d agoCALQUENCE (ACALABRUTINIB) — FDA approvalCALQUENCE

    Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL

    full page →CALQUENCE →fda approvals ↗
    ›Oct 31, 2017approval3199d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

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

    full page →IBANDRONATE SODIUM →fda approvals ↗
    ›Nov 1, 2017approval3198d agoENJUVIA (ESTROGENS, CONJUGATED SYNTHETIC B) — FDA approvalENJUVIA

    Sponsor: ASPEN. Form: TABLET. Route: ORAL

    full page →ENJUVIA →fda approvals ↗
    ›Nov 1, 2017approval3198d agoESTRING (ESTRADIOL) — FDA approvalestradiol ER

    Sponsor: PFIZER. Form: INSERT, EXTENDED RELEASE. Route: VAGINAL

    full page →estradiol ER →fda approvals ↗
    ›Nov 1, 2017approval3198d agoDIVIGEL (ESTRADIOL) — FDA approvalVertical Pharmaceuticals LLC

    Sponsor: VERTICAL PHARMS. Form: GEL. Route: TRANSDERMAL

    full page →fda approvals ↗
    ›Nov 1, 2017approval3198d agoCENESTIN (ESTROGENS, CONJUGATED SYNTHETIC A) — FDA approvalCENESTIN

    Sponsor: ASPEN. Form: TABLET. Route: ORAL

    full page →CENESTIN →fda approvals ↗
    3193d ago
    XTAMPZA ER (OXYCODONE) — FDA approvaloxycodone ER

    Sponsor: COLLEGIUM PHARM INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →oxycodone ER →fda approvals ↗
    ›Nov 6, 2017approval3193d agoDAYTRANA (METHYLPHENIDATE) — FDA approvalNoven Pharmaceuticals Inc

    Sponsor: NOVEN PHARMS INC. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

    full page →fda approvals ↗
    ›Nov 7, 2017approval3192d agoHYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

    Sponsor: ACTAVIS LABS FL INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Nov 9, 2017approval3190d agoVRAYLAR (CARIPRAZINE HYDROCHLORIDE) — FDA approvalCARIPRAZINE HYDROCHLORIDE

    Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

    full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗
    ›Nov 9, 2017approval3190d agoVRAYLAR (CARIPRAZINE HYDROCHLORIDE) — FDA approvalCARIPRAZINE HYDROCHLORIDE

    Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

    full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗
    3186d ago
    OMEPRAZOLE — FDA approvalomeprazole DR

    Sponsor: DEXCEL PHARMA. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →omeprazole DR →fda approvals ↗
    $BMY64.73-0.89%
    $ABBV246.00-1.97%
    $JNJ251.81-1.77%
    $MNKD3.8350-1.92%
    $ABBV246.00-1.97%
    $NVS153.49-1.70%
    $AMPH19.94-2.16%
    $AMGN377.50-1.99%
    $EXEL53.08+0.08%
    $ABBV246.00-1.97%
    $NVS153.49-1.70%
    $UTHR516.34-0.27%
    $IGC0.2670+0.41%
    $ASPU0.2893-0.26%
    $AZN169.64-0.99%
    $PFE24.91-0.42%
    $ASPU0.2893-0.26%
    $COLL35.39-1.64%
    $ABBV246.00-1.97%
    $ABBV246.00-1.97%