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calendar

29,322 catalysts · 9,833 approval · 5,000 device 510k · 4,728 grant · 2,630 8k filing · 2,000 device pma · 2,000 device recall

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  • approval9,833
  • 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 May 15, 2017

    26
    ›May 15, 2017approval3368d agoALLI (ORLISTAT) — FDA approvalH2-Pharma LLC

    Sponsor: HALEON US HOLDINGS. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›May 16, 2017approval3367d agoCAPRELSA (VANDETANIB) — FDA approvalvandetanib

    Sponsor: GENZYME CORP. Form: TABLET. Route: ORAL

    full page →vandetanib →fda approvals ↗
    ›May 17, 2017approval3366d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›May 17, 2017approval3366d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

    full page →fda approvals ↗
    ›May 17, 2017approval3366d agoKALYDECO (IVACAFTOR) — FDA approvalivacaftor

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

    full page →ivacaftor →fda approvals ↗
    ›May 18, 2017approval3365d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›May 18, 2017approval3365d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›May 18, 2017approval3365d agoYONDELIS (TRABECTEDIN) — FDA approvalJOHNSON & JOHNSON

    Sponsor: JANSSEN PRODS. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›May 19, 2017approval3364d agoIMPLANON (ETONOGESTREL) — FDA approvaletonogestrel CR

    Sponsor: ORGANON. Form: IMPLANT. Route: IMPLANTATION

    full page →etonogestrel CR →fda approvals ↗
    ›May 19, 2017approval3364d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: IMPAX LABS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›May 19, 2017approval3364d agoSYNAREL (NAFARELIN ACETATE) — FDA approvalnafarelin acetate

    Sponsor: PFIZER. Form: SPRAY, METERED. Route: NASAL

    full page →nafarelin acetate →fda approvals ↗
    ›May 19, 2017approval3364d agoSYNAREL (NAFARELIN ACETATE) — FDA approvalnafarelin acetate

    Sponsor: PFIZER. Form: SPRAY, METERED. Route: NASAL

    full page →nafarelin acetate →fda approvals ↗
    ›May 19, 2017approval3364d agoLUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: ABBVIE ENDOCRINE INC. Form: POWDER. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›May 19, 2017approval3364d agoLUPRON (LEUPROLIDE ACETATE) — FDA approvalInvaGen Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›May 19, 2017approval3364d agoDEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) — FDA approvalMallinckrodt LLC

    Sponsor: IMPAX LABS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›May 19, 2017approval3364d agoLEUPROLIDE ACETATE — FDA approvalInvaGen Pharmaceuticals Inc

    Sponsor: SUN PHARM. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›May 19, 2017approval3364d agoLEUPROLIDE ACETATE — FDA approvalInvaGen Pharmaceuticals Inc

    Sponsor: SUN PHARM. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›May 19, 2017approval3364d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

    Sponsor: SANDOZ. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗
    ›May 19, 2017approval3364d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

    Sponsor: SANDOZ. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗
    ›May 19, 2017approval3364d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›May 19, 2017approval3364d agoSUPPRELIN LA (HISTRELIN ACETATE) — FDA approvalEndo Pharmaceuticals Inc

    Sponsor: ENDO OPERATIONS. Form: IMPLANT. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›May 19, 2017approval3364d agoSUPPRELIN LA (HISTRELIN ACETATE) — FDA approvalEndo Pharmaceuticals Inc

    Sponsor: ENDO OPERATIONS. Form: IMPLANT. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›May 19, 2017approval3364d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›May 19, 2017approval3364d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

    Sponsor: MEITHEAL. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗
    ›May 19, 2017approval3364d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

    Sponsor: MEITHEAL. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗
    ›May 19, 2017approval3364d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

    Sponsor: MEITHEAL. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗

    Week of May 22, 2017

    24
    ›May 22, 2017approval3361d agoSAXENDA (LIRAGLUTIDE) — FDA approvalNovo Nordisk Inc

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›May 22, 2017approval
    ← prev
    page 2 of 587
    next →
    3361d ago
    HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›May 22, 2017approval3361d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

    Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

    full page →tocilizumab →fda approvals ↗
    ›May 22, 2017approval3361d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

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

    full page →tocilizumab →fda approvals ↗
    ›May 23, 2017approval3360d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›May 23, 2017approval3360d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2017approval3360d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2017approval3360d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›May 23, 2017approval3360d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›May 23, 2017approval3360d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2017approval3360d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›May 23, 2017approval3360d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2017approval3360d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2017approval3360d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

    Sponsor: PHARMOBEDIENT. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›May 23, 2017approval3360d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2017approval3360d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›May 23, 2017approval3360d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

    Sponsor: BARR. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›May 23, 2017approval3360d agoZUBSOLV (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalEdenbridge Pharmaceuticals LLC

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

    full page →fda approvals ↗
    ›May 23, 2017approval3360d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›May 23, 2017approval3360d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›May 23, 2017approval3360d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›May 25, 2017approval3358d agoSODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (SODIUM CHLORIDE) — FDA approvalRevalesio Corp

    Sponsor: LABORATORIOS GRIFOLS. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›May 26, 2017approval3357d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

    Sponsor: VISTAPHARM LLC. Form: SOLUTION. Route: ORAL

    full page →METHADONE HYDROCHLORIDE →fda approvals ↗
    ›May 26, 2017approval3357d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

    Sponsor: ACTAVIS ELIZABETH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗
    $VERX12.91+2.46%
    $VERX12.91+2.46%
    $JNJ251.81-1.77%
    $OGN13.56+0.07%
    $PFE24.91-0.42%
    $PFE24.91-0.42%
    $AMRX18.32-0.97%
    $AMRX18.32-0.97%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $AMRX18.32-0.97%