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calendar

31,626 catalysts · 12,072 approval · 5,000 device 510k · 4,728 grant · 3,035 8k filing · 2,000 device pma · 2,000 device recall

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2026-08-10: 65 catalysts2026-08-11: 16 catalysts2026-08-12: 19 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 2 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 20 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 8 catalysts2026-11-03: 16 catalysts2026-11-04: 22 catalysts2026-11-05: 36 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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  • approval12,072
  • device 510k5,000
  • grant4,728
  • 8k filing3,035
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • earnings577
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Oct 24, 2016

    4
    ›Oct 28, 2016approval3574d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

    Sponsor: CUBIST PHARMS LLC. Form: POWDER. Route: INTRAVENOUS

    full page →tedizolid phosphate →fda approvals ↗
    ›Oct 28, 2016approval3574d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

    full page →METHADONE HYDROCHLORIDE →fda approvals ↗
    ›Oct 28, 2016approval3574d agoMETHYLIN ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETHYLIN ER

    Sponsor: SPECGX LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →METHYLIN ER →fda approvals ↗
    ›Oct 28, 2016approval3574d agoMETHYLIN ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETHYLIN ER

    Sponsor: SPECGX LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →METHYLIN ER →fda approvals ↗

    Week of Oct 31, 2016

    9
    ›Oct 31, 2016approval3571d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

    full page →METHADONE HYDROCHLORIDE →fda approvals ↗
    ›Oct 31, 2016approval

    Week of Nov 7, 2016

    4
    ›Nov 8, 2016approval3563d agoDILTIAZEM HYDROCHLORIDE — FDA approvalBausch Health US LLC

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

    full page →fda approvals ↗
    ›Nov 8, 2016approval

    Week of Nov 14, 2016

    7
    ›Nov 14, 2016approval3557d agoFLUOROURACIL — FDA approvalEfudex

    Sponsor: SAGENT PHARMS INC. Form: INJECTABLE. Route: INJECTION

    full page →Efudex →fda approvals ↗
    ›Nov 14, 2016approval

    Week of Nov 21, 2016

    4
    ›Nov 21, 2016approval3550d agoSOLIQUA 100/33 (INSULIN GLARGINE) — FDA approvalToujeo LA

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

    full page →Toujeo LA →fda approvals ↗
    ›Nov 21, 2016approval

    Week of Nov 28, 2016

    10
    ›Nov 28, 2016approval3543d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Nov 29, 2016approval

    Week of Dec 5, 2016

    2
    ›Dec 9, 2016approval3532d agoVIVITROL (NALTREXONE) — FDA approvalnaltrexone ER

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

    full page →naltrexone ER →fda approvals ↗
    ›Dec 9, 2016approval

    Week of Dec 12, 2016

    10
    ›Dec 12, 2016approval3529d agoVIVITROL (NALTREXONE) — FDA approvalnaltrexone ER

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

    full page →naltrexone ER →fda approvals ↗
    ›Dec 13, 2016approval
    ← prev
    page 35 of 633
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    3571d ago
    BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Nov 1, 2016approval3570d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

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

    full page →tedizolid phosphate →fda approvals ↗
    ›Nov 2, 2016approval3569d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

    full page →divalproex sodium DR →fda approvals ↗
    ›Nov 2, 2016approval3569d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

    full page →divalproex sodium DR →fda approvals ↗
    ›Nov 2, 2016approval3569d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

    full page →divalproex sodium DR →fda approvals ↗
    ›Nov 2, 2016approval3569d agoDIGOXIN — FDA approvalDIGOXIN

    Sponsor: RISING. Form: TABLET. Route: ORAL

    full page →DIGOXIN →fda approvals ↗
    ›Nov 4, 2016approval3567d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

    Sponsor: IMMUNEX. Form: SYRINGE

    full page →fda approvals ↗
    ›Nov 4, 2016approval3567d agoFENTANYL-100 (FENTANYL) — FDA approvalNiu Technologies

    Sponsor: KINDEVA. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

    full page →fda approvals ↗
    3563d ago
    TIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

    full page →fda approvals ↗
    ›Nov 9, 2016approval3562d agoANTARA (MICRONIZED) (FENOFIBRATE) — FDA approvalFENOFIBRATE

    Sponsor: LUPIN. Form: CAPSULE. Route: ORAL

    full page →FENOFIBRATE →fda approvals ↗
    ›Nov 10, 2016approval3561d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗
    3557d ago
    HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: NOVEL LABS INC. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 15, 2016approval3556d agoFOLLISTIM AQ (FOLLITROPIN ALFA/BETA) — FDA approvalfollitropin beta

    Sponsor: ORGANON USA LLC. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →follitropin beta →fda approvals ↗
    ›Nov 16, 2016approval3555d agoKINERET (ANAKINRA) — FDA approvalSobi Inc

    Sponsor: BIOVITRUM AB. Form: VIAL. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Nov 17, 2016approval3554d agoBOSULIF (BOSUTINIB MONOHYDRATE) — FDA approvalAlembic Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Nov 18, 2016approval3553d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

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

    full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗
    ›Nov 18, 2016approval3553d agoADZENYS XR-ODT (AMPHETAMINE) — FDA approvalTraws Pharma, Inc.

    Sponsor: NEOS THERAPS. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    3550d ago
    HYDROMORPHONE HYDROCHLORIDE — FDA approvalHYDROMORPHONE HYDROCHLORIDE

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

    full page →HYDROMORPHONE HYDROCHLORIDE →fda approvals ↗
    ›Nov 21, 2016approval3550d agoXULTOPHY 100/3.6 (INSULIN DEGLUDEC) — FDA approvalNovo Nordisk Inc

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Nov 23, 2016approval3548d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    3542d ago
    AUBAGIO (TERIFLUNOMIDE) — FDA approvalteriflunomide

    Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

    full page →teriflunomide →fda approvals ↗
    ›Nov 29, 2016approval3542d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Nov 29, 2016approval3542d agoANTARA (MICRONIZED) (FENOFIBRATE) — FDA approvalFENOFIBRATE

    Sponsor: LUPIN. Form: CAPSULE. Route: ORAL

    full page →FENOFIBRATE →fda approvals ↗
    ›Nov 30, 2016approval3541d agoCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Dec 1, 2016approval3540d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: NOVEL LABS INC. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 1, 2016approval3540d agoLANOXIN PEDIATRIC (DIGOXIN) — FDA approvalDIGOXIN

    Sponsor: AZURITY. Form: INJECTABLE. Route: INJECTION

    full page →DIGOXIN →fda approvals ↗
    ›Dec 1, 2016approval3540d agoOMEPRAZOLE — FDA approvalomeprazole DR

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

    full page →omeprazole DR →fda approvals ↗
    ›Dec 2, 2016approval3539d agoJARDIANCE (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

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

    full page →SYNJARDY →fda approvals ↗
    ›Dec 2, 2016approval3539d agoIRBESARTAN — FDA approvalIRBESARTAN

    Sponsor: JUBILANT GENERICS. Form: TABLET. Route: ORAL

    full page →IRBESARTAN →fda approvals ↗
    3532d ago
    SYNJARDY 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 ↗
    3528d ago
    OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: SANALUZ. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 13, 2016approval3528d agoHUMATROPE (SOMATROPIN) — FDA approvalEMD Serono Inc

    Sponsor: LILLY. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Dec 14, 2016approval3527d agoFLUOROURACIL — FDA approvalExtrovis AG

    Sponsor: EUGIA PHARMA SPECLTS. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Dec 14, 2016approval3527d agoXELODA (CAPECITABINE) — FDA approvalArmas Pharmaceuticals Inc

    Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 15, 2016approval3526d agoFOLLISTIM AQ (FOLLITROPIN ALFA/BETA) — FDA approvalfollitropin beta

    Sponsor: ORGANON USA LLC. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →follitropin beta →fda approvals ↗
    ›Dec 15, 2016approval3526d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

    full page →acetaminophen ER →fda approvals ↗
    ›Dec 15, 2016approval3526d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Dec 15, 2016approval3526d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    ›Dec 15, 2016approval3526d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

    full page →fda approvals ↗
    $ALKS49.40+0.47%
    $ALKS49.40+0.47%
    $ABBV245.40-0.26%
    $IGC0.2670+0.41%
    $ABBV245.40-0.26%
    $AMGN413.75+0.68%
    $BMY65.03+0.47%
    $NIU2.0900-15.04%
    $ABBV245.40-0.26%
    $AMRX18.00-0.74%
    $AMRX18.00-0.74%
    $TRAW
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $AMRX18.00-0.74%
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%