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calendar

28,710 catalysts · 9,430 approval · 5,000 device 510k · 4,728 grant · 2,761 8k filing · 2,000 device pma · 2,000 device recall

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  • approval9,430
  • device 510k5,000
  • grant4,728
  • 8k filing2,761
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • earnings349
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Oct 15, 2018

    4
    ›Oct 18, 2018approval2849d agoBOSULIF (BOSUTINIB MONOHYDRATE) — FDA approvalAlembic Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Oct 18, 2018approval2849d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Oct 19, 2018approval2848d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

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

    full page →dupilumab →fda approvals ↗
    ›Oct 19, 2018approval2848d agoSAXENDA (LIRAGLUTIDE) — FDA approvalNovo Nordisk Inc

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗

    Week of Oct 22, 2018

    13
    ›Oct 23, 2018approval2844d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Oct 24, 2018approval

    Week of Oct 29, 2018

    30
    ›Oct 29, 2018approval2838d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Oct 29, 2018approval

    Week of Nov 5, 2018

    3
    ›Nov 6, 2018approval2830d agoPRALUENT (ALIROCUMAB) — FDA approvalalirocumab

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

    full page →alirocumab →fda approvals ↗
    ›Nov 7, 2018approval
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    page 17 of 575
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    2843d ago
    HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: ALVOGEN. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Oct 24, 2018approval2843d agoIRBESARTAN — FDA approvalIRBESARTAN

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

    full page →IRBESARTAN →fda approvals ↗
    ›Oct 25, 2018approval2842d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

    Sponsor: ACTELION. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Oct 25, 2018approval2842d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

    full page →fda approvals ↗
    ›Oct 25, 2018approval2842d agoAFREZZA (INSULIN RECOMBINANT HUMAN) — FDA approvalinsulin human

    Sponsor: MANNKIND. Form: POWDER. Route: INHALATION

    full page →insulin human →fda approvals ↗
    ›Oct 26, 2018approval2841d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: INDIVIOR. Form: FILM. Route: BUCCAL, SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Oct 26, 2018approval2841d agoXTAMPZA ER (OXYCODONE) — FDA approvaloxycodone ER

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

    full page →oxycodone ER →fda approvals ↗
    ›Oct 26, 2018approval2841d agoSYNJARDY XR (EMPAGLIFLOZIN) — FDA approval(empagliflozin + metformin hydrochloride ER)

    Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →(empagliflozin + metformin hydrochloride ER) →fda approvals ↗
    ›Oct 26, 2018approval2841d agoGLYXAMBI (EMPAGLIFLOZIN) — FDA approval(empagliflozin + linagliptin)

    Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

    full page →(empagliflozin + linagliptin) →fda approvals ↗
    ›Oct 26, 2018approval2841d agoSYNJARDY (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

    Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

    full page →SYNJARDY →fda approvals ↗
    ›Oct 26, 2018approval2841d agoJARDIANCE (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

    Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

    full page →SYNJARDY →fda approvals ↗
    ›Oct 28, 2018approval2839d agoBIJUVA (ESTRADIOL) — FDA approval(estradiol + progesterone)

    Sponsor: MAYNE PHARMA. Form: CAPSULE. Route: ORAL

    full page →(estradiol + progesterone) →fda approvals ↗
    2838d ago
    OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Oct 30, 2018approval2837d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›Oct 30, 2018approval2837d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

    Sponsor: HIKMA INTL PHARMS. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Oct 30, 2018approval2837d agoHYRIMOZ (ADALIMUMAB-ADAZ) — FDA approvalHYRIMOZ

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

    full page →HYRIMOZ →fda approvals ↗
    ›Oct 31, 2018approval2836d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

    Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL

    full page →fda approvals ↗
    ›Oct 31, 2018approval2836d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: RUBICON RESEARCH. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Oct 31, 2018approval2836d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Oct 31, 2018approval2836d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Oct 31, 2018approval2836d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: TEVA PHARMS USA. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›Oct 31, 2018approval2836d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Oct 31, 2018approval2836d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Oct 31, 2018approval2836d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Oct 31, 2018approval2836d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Oct 31, 2018approval2836d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

    Sponsor: PHARMOBEDIENT. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›Oct 31, 2018approval2836d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Oct 31, 2018approval2836d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Oct 31, 2018approval2836d agoXTRELUS (GUAIFENESIN) — FDA approvalECI Pharmaceuticals LLC

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

    full page →fda approvals ↗
    ›Oct 31, 2018approval2836d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

    Sponsor: BARR. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›Oct 31, 2018approval2836d agoZUBSOLV (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalEdenbridge Pharmaceuticals LLC

    Sponsor: EDENBRIDGE PHARMS. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›Oct 31, 2018approval2836d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Oct 31, 2018approval2836d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Oct 31, 2018approval2836d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: AMNEAL PHARMS. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›Oct 31, 2018approval2836d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Nov 1, 2018approval2835d agoPROBUPHINE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Nov 2, 2018approval2834d agoGADAVIST (GADOBUTROL) — FDA approval

    Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Nov 2, 2018approval2834d agoEOVIST (GADOXETATE DISODIUM) — FDA approval

    Sponsor: BAYER HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Nov 2, 2018approval2834d agoLORBRENA (LORLATINIB) — FDA approvallorlatinib

    Sponsor: PFIZER. Form: TABLET. Route: ORAL

    full page →lorlatinib →fda approvals ↗
    ›Nov 2, 2018approval2834d agoDSUVIA (SUFENTANIL CITRATE) — FDA approvalVertical Pharmaceuticals LLC

    Sponsor: VERTICAL PHARMS. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›Nov 2, 2018approval2834d agoZINGO (LIDOCAINE HYDROCHLORIDE) — FDA approvalPowder Pharmaceuticals Inc

    Sponsor: POWDER PHARMS. Form: SYSTEM. Route: INTRADERMAL

    full page →fda approvals ↗
    2829d ago
    XARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Nov 7, 2018approval2829d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    $REGN774.68+1.84%
    $IGC0.2670+0.41%
    $REGN774.68+1.84%
    $IGC0.2670+0.41%
    $MNKD3.9600+4.21%
    $COLL35.73+0.42%
    $IGC0.2670+0.41%
    $PYPD4.4500+2.06%
    $INDV40.10-2.17%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $AMRX18.48-1.96%
    $IGC0.2670+0.41%
    $PFE25.61+0.77%