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calendar

28,847 catalysts · 9,600 approval · 5,000 device 510k · 4,728 grant · 2,728 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2017-08-22×clear all

type

approval9,600
device 510k5,000
grant4,728
8k filing2,728
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

earnings325

phase 2 completion172

therapy area

Oncology148
Infectious Disease46
Cardiology37
Immunology35
Dermatology31
Pulmonology22
Women's Health19
Ophthalmology16
Pain15

Week of Jul 9, 2018

›Jul 12, 2018approval2946d agoOMEPRAZOLE — FDA approvalomeprazole DR

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

full page →omeprazole DR →fda approvals ↗

›Jul 13, 2018approval2945d agoXTANDI (ENZALUTAMIDE) — FDA approvalenzalutamide

Sponsor: ASTELLAS. Form: CAPSULE. Route: ORAL

full page →enzalutamide →fda approvals ↗

Week of Jul 16, 2018

›Jul 16, 2018approval2942d agoADDERALL XR 10 (AMPHETAMINE ASPARTATE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Jul 17, 2018approval

Week of Jul 23, 2018

›Jul 23, 2018approval2935d agoORILISSA (ELAGOLIX SODIUM) — FDA approvalelagolix sodium

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →elagolix sodium →fda approvals ↗

›Jul 23, 2018approval

Week of Jul 30, 2018

›Jul 30, 2018approval2928d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

›Jul 30, 2018approval

Week of Aug 6, 2018

›Aug 7, 2018approval2920d agoKETALAR (KETAMINE HYDROCHLORIDE) — FDA approvalPar Pharmaceutical Inc

Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Aug 7, 2018approval

Week of Aug 13, 2018

›Aug 13, 2018approval2914d agoFEXOFENADINE HYDROCHLORIDE ALLERGY (FEXOFENADINE HYDROCHLORIDE) — FDA approvalPERRIGO Co plc

Sponsor: UNIQUE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Aug 15, 2018approval

Week of Aug 20, 2018

›Aug 20, 2018approval2907d agoDIACOMIT (STIRIPENTOL) — FDA approvalstiripentol

Sponsor: BIOCODEX SA. Form: CAPSULE. Route: ORAL

full page →stiripentol →fda approvals ↗

›Aug 20, 2018approval

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page 11 of 577

2941d ago

IMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →SUMATRIPTAN SUCCINATE →fda approvals ↗

›Jul 19, 2018approval2939d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Jul 20, 2018approval2938d agoGEMCITABINE HYDROCHLORIDE — FDA approvalGEMCITABINE HYDROCHLORIDE

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

full page →GEMCITABINE HYDROCHLORIDE →fda approvals ↗

›Jul 20, 2018approval2938d agoSUMATRIPTAN AND NAPROXEN SODIUM (NAPROXEN SODIUM) — FDA approvalBayer HealthCare Pharmaceuticals Inc

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

full page →fda approvals ↗

›Jul 20, 2018approval2938d agoPRALUENT (ALIROCUMAB) — FDA approvalalirocumab

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

full page →alirocumab →fda approvals ↗

2935d ago

LAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

›Jul 23, 2018approval2935d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

›Jul 23, 2018approval2935d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

›Jul 23, 2018approval2935d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

›Jul 24, 2018approval2934d agoMEDROL (METHYLPREDNISOLONE) — FDA approvalMEDROL

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →MEDROL →fda approvals ↗

›Jul 24, 2018approval2934d agoDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗

›Jul 24, 2018approval2934d agoSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) — FDA approvalmethylprednisolone sodium succinate

Sponsor: PHARMACIA AND UPJOHN. Form: INJECTABLE. Route: INJECTION

full page →methylprednisolone sodium succinate →fda approvals ↗

›Jul 25, 2018approval2933d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

Sponsor: BAYER. Form: TABLET. Route: ORAL

full page →NAPROXEN SODIUM →fda approvals ↗

›Jul 26, 2018approval2932d agoGADAVIST (GADOBUTROL) — FDA approval

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

full page →fda approvals ↗

›Jul 26, 2018approval2932d agoEOVIST (GADOXETATE DISODIUM) — FDA approval

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

full page →fda approvals ↗

›Jul 27, 2018approval2931d agoCARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER (NICARDIPINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: CHIESI. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

2928d ago

DALFAMPRIDINE — FDA approvalSolaxa Inc

Sponsor: ALKEM LABS LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Aug 1, 2018approval2926d agoCABERGOLINE — FDA approvalCABERGOLINE

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

full page →CABERGOLINE →fda approvals ↗

›Aug 2, 2018approval2925d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

Sponsor: ABBVIE INC. Form: VIAL

full page →adalimumab →fda approvals ↗

›Aug 2, 2018approval2925d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

2920d ago

ORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

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

full page →(ivacaftor + lumacaftor) →fda approvals ↗

›Aug 8, 2018approval2919d agoPOTELIGEO (MOGAMULIZUMAB-KPKC) — FDA approvalmogamulizumab

Sponsor: KYOWA KIRIN. Form: INJECTABLE. Route: INJECTION

full page →mogamulizumab →fda approvals ↗

›Aug 8, 2018approval2919d agoJORNAY PM (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

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

full page →fda approvals ↗

›Aug 10, 2018approval2917d agoHIBICLENS (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

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

full page →fda approvals ↗

2912d ago

KALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

full page →fda approvals ↗

›Aug 15, 2018approval2912d agoKALYDECO (IVACAFTOR) — FDA approvalivacaftor

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

full page →ivacaftor →fda approvals ↗

›Aug 15, 2018approval2912d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

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

full page →(ivacaftor + lumacaftor) →fda approvals ↗

›Aug 15, 2018approval2912d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

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

full page →Midol →fda approvals ↗

›Aug 15, 2018approval2912d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalANI PHARMACEUTICALS INC

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

full page →fda approvals ↗

›Aug 15, 2018approval2912d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalLupin Ltd

Sponsor: WATSON LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Aug 15, 2018approval2912d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Aug 15, 2018approval2912d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

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

full page →fda approvals ↗

›Aug 15, 2018approval2912d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

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

full page →fda approvals ↗

›Aug 15, 2018approval2912d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

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

full page →fda approvals ↗

›Aug 15, 2018approval2912d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

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

full page →hydrocodone bitartrate ER →fda approvals ↗

›Aug 15, 2018approval2912d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Aug 16, 2018approval2911d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Aug 16, 2018approval2911d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗

›Aug 17, 2018approval2910d agoXELJANZ XR (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

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

full page →tofacitinib citrate ER →fda approvals ↗

›Aug 17, 2018approval2910d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

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

full page →fda approvals ↗

›Aug 17, 2018approval2910d agoDIVIGEL (ESTRADIOL) — FDA approvalVertical Pharmaceuticals LLC

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

full page →fda approvals ↗

2907d ago

DIACOMIT (STIRIPENTOL) — FDA approvalstiripentol

Sponsor: BIOCODEX SA. Form: FOR SUSPENSION. Route: ORAL

full page →stiripentol →fda approvals ↗

$PRGO10.62-0.61%

$ABBV243.80-0.53%

$PFE25.32+1.18%

$COLL35.73+0.42%

$AMRX18.48-1.96%

$VERX12.39-7.54%

$ABBV243.80-0.53%

$VERX12.39-7.54%

$REGN758.71-0.07%

$VERX12.39-7.54%

$ANIP79.65-0.51%

$PFE25.32+1.18%

$BMY65.79+0.49%