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calendar

29,283 catalysts · 9,821 approval · 5,000 device 510k · 4,728 grant · 2,603 8k filing · 2,000 device pma · 2,000 device recall

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  • approval9,821
  • device 510k5,000
  • grant4,728
  • 8k filing2,603
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
  • earnings311
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jun 19, 2017

    1
    ›Jun 23, 2017approval3328d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗

    Week of Jun 26, 2017

    12
    ›Jun 28, 2017approval3323d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Jun 29, 2017approval3322d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAurobindo Pharma Ltd

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

    full page →fda approvals ↗
    ›Jun 29, 2017approval3322d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAurobindo Pharma Ltd

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

    full page →fda approvals ↗
    ›Jun 29, 2017approval3322d agoOTEZLA (APREMILAST) — FDA approvalapremilast

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

    full page →apremilast →fda approvals ↗
    ›Jun 29, 2017approval3322d agoTRIPTODUR KIT (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

    Sponsor: AZURITY. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

    full page →triptorelin pamoate ER →fda approvals ↗
    ›Jun 30, 2017approval3321d agoQUETIAPINE FUMARATE — FDA approvalquetiapine fumarate ER

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

    full page →quetiapine fumarate ER →fda approvals ↗
    ›Jun 30, 2017approval3321d agoQUETIAPINE FUMARATE — FDA approvalquetiapine fumarate ER

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

    full page →quetiapine fumarate ER →fda approvals ↗
    ›Jun 30, 2017approval3321d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Jun 30, 2017approval3321d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

    full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
    ›Jun 30, 2017approval3321d agoBUPROPION HYDROCHLORIDE — FDA approvalSciegen Pharmaceuticals Inc

    Sponsor: SCIEGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jun 30, 2017approval3321d agoBUPROPION HYDROCHLORIDE — FDA approvalIpca Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jun 30, 2017approval3321d agoBUPROPION HYDROCHLORIDE — FDA approvalIpca Pharmaceuticals Inc

    Sponsor: IMPAX LABS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗

    Week of Jul 3, 2017

    2
    ›Jul 5, 2017approval3316d agoOMEPRAZOLE — FDA approvalomeprazole DR

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

    full page →omeprazole DR →fda approvals ↗
    ›Jul 7, 2017approval

    Week of Jul 10, 2017

    5
    ›Jul 10, 2017approval3311d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

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

    full page →fda approvals ↗
    ›Jul 11, 2017approval

    Week of Jul 17, 2017

    3
    ›Jul 17, 2017approval3304d agoTRANEXAMIC ACID — FDA approvalZydus Therapeutics Inc

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

    full page →fda approvals ↗
    ›Jul 17, 2017approval

    Week of Jul 24, 2017

    12
    ›Jul 24, 2017approval3297d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

    Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

    full page →enzalutamide →fda approvals ↗
    ›Jul 26, 2017approval

    Week of Jul 31, 2017

    12
    ›Jul 31, 2017approval3290d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗
    ›Jul 31, 2017approval

    Week of Aug 7, 2017

    3
    ›Aug 7, 2017approval3283d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

    Sponsor: ASCENT PHARMS INC. Form: TABLET. Route: ORAL

    full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
    ›Aug 8, 2017approval
    ← prev
    page 4 of 586
    next →
    3314d ago
    RECLAST (ZOLEDRONIC ACID) — FDA approvalZOLEDRONIC ACID

    Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

    full page →ZOLEDRONIC ACID →fda approvals ↗
    3310d ago
    ENBREL (ETANERCEPT) — FDA approvalAMGEN INC

    Sponsor: IMMUNEX. Form: SYRINGE

    full page →fda approvals ↗
    ›Jul 11, 2017approval3310d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

    Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

    full page →blinatumomab →fda approvals ↗
    ›Jul 11, 2017approval3310d agoLUPRON (LEUPROLIDE ACETATE) — FDA approvalInvaGen Pharmaceuticals Inc

    Sponsor: ABBVIE ENDOCRINE INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Jul 13, 2017approval3308d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

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

    full page →guselkumab →fda approvals ↗
    3304d ago
    FLUOCINOLONE ACETONIDE — FDA approvalEclipse Life Sciences Inc

    Sponsor: PADAGIS ISRAEL. Form: OIL/DROPS. Route: OTIC

    full page →fda approvals ↗
    ›Jul 18, 2017approval3303d agoCEFUROXIME AXETIL — FDA approvalOrchid Pharma Inc

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

    full page →fda approvals ↗
    3295d ago
    VICTOZA (LIRAGLUTIDE) — FDA approvalSaxenda

    Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →Saxenda →fda approvals ↗
    ›Jul 27, 2017approval3294d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›Jul 27, 2017approval3294d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›Jul 27, 2017approval3294d agoABILIFY MAINTENA KIT (ARIPIPRAZOLE) — FDA approvalaripiprazole LA

    Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

    full page →aripiprazole LA →fda approvals ↗
    ›Jul 27, 2017approval3294d agoPRALUENT (ALIROCUMAB) — FDA approvalalirocumab

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

    full page →alirocumab →fda approvals ↗
    ›Jul 28, 2017approval3293d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

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

    full page →fda approvals ↗
    ›Jul 28, 2017approval3293d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

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

    full page →fda approvals ↗
    ›Jul 28, 2017approval3293d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

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

    full page →fda approvals ↗
    ›Jul 28, 2017approval3293d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

    Sponsor: MYLAN. Form: TABLET. Route: ORAL

    full page →DOXYCYCLINE HYCLATE →fda approvals ↗
    ›Jul 28, 2017approval3293d agoPROBUPHINE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

    Sponsor: REACX PHARMS. Form: IMPLANT. Route: IMPLANTATION

    full page →fda approvals ↗
    ›Jul 28, 2017approval3293d agoPROBUPHINE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

    Sponsor: REACX PHARMS. Form: IMPLANT. Route: IMPLANTATION

    full page →fda approvals ↗
    3290d ago
    KALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

    full page →fda approvals ↗
    ›Jul 31, 2017approval3290d agoKALYDECO (IVACAFTOR) — FDA approvalivacaftor

    Sponsor: VERTEX PHARMS INC. Form: GRANULE. Route: ORAL

    full page →ivacaftor →fda approvals ↗
    ›Jul 31, 2017approval3290d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

    Sponsor: RISING. Form: INJECTABLE. Route: INJECTION

    full page →ondansetron hydrochloride CR →fda approvals ↗
    ›Jul 31, 2017approval3290d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

    Sponsor: TAKEDA PHARMS USA. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Jul 31, 2017approval3290d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

    Sponsor: TAKEDA PHARMS USA. Form: TABLET, CHEWABLE. Route: ORAL

    full page →fda approvals ↗
    ›Aug 1, 2017approval3289d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

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

    full page →dulaglutide →fda approvals ↗
    ›Aug 1, 2017approval3289d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

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

    full page →dulaglutide →fda approvals ↗
    ›Aug 2, 2017approval3288d agoJUXTAPID (LOMITAPIDE MESYLATE) — FDA approvalChiesi USA Inc

    Sponsor: CHIESI. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Aug 2, 2017approval3288d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

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

    full page →fda approvals ↗
    ›Aug 3, 2017approval3287d agoVYXEOS (CYTARABINE) — FDA approvalMeitheal Pharmaceuticals Inc

    Sponsor: JAZZ PHARMS THERAP. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Aug 3, 2017approval3287d agoQVAR REDIHALER (BECLOMETHASONE DIPROPIONATE) — FDA approvalSOLIGENIX, INC.

    Sponsor: NORTON WATERFORD. Form: AEROSOL, METERED. Route: INHALATION

    full page →fda approvals ↗
    3282d ago
    DILTIAZEM HYDROCHLORIDE — FDA approvalZydus Therapeutics Inc

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

    full page →fda approvals ↗
    ›Aug 10, 2017approval3280d agoFENTANYL-75 (FENTANYL) — FDA approvalDifGen Pharmaceuticals LLC

    Sponsor: DIFGEN PHARMS. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

    full page →fda approvals ↗
    $IGC0.2670+0.41%
    $AMGN385.16-0.64%
    $BMY65.31+0.69%
    $ABBV250.94-2.51%
    $IGC0.2670+0.41%
    $AMGN385.16-0.64%
    $NVO47.08-8.78%
    $IGC0.2670+0.41%
    $REGN762.63+3.29%
    $AMGN385.16-0.64%
    $LLY1148.84-0.53%
    $VERX12.91+2.46%
    $VERX12.91+2.46%
    $LLY1148.84-0.53%
    $ABBV250.94-2.51%
    $SNGX