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calendar

28,223 catalysts · 17,796 approval · 4,110 device 510k · 2,473 grant · 1,581 device recall · 1,359 device pma · 904 recall

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  • approval17,796
  • device 510k4,110
  • grant2,473
  • device recall1,581
  • device pma1,359
  • recall904
therapy area

no tagged catalysts yet

Week of Jul 15, 2019

1
›Jul 19, 2019approval2601d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Week of Jul 22, 2019

17
›Jul 22, 2019approval2598d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗
›Jul 22, 2019approval2598d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

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

full page →Midol →fda approvals ↗
›Jul 22, 2019approval2598d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

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

full page →Midol →fda approvals ↗
›Jul 22, 2019approval2598d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

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

full page →hydrocodone bitartrate ER →fda approvals ↗
›Jul 22, 2019approval2598d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalANI PHARMACEUTICALS INC

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

full page →fda approvals ↗
›Jul 22, 2019approval2598d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

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

full page →fda approvals ↗
›Jul 22, 2019approval2598d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

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

full page →fda approvals ↗
›Jul 22, 2019approval2598d 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 ↗
›Jul 23, 2019approval2597d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

Sponsor: BAYER. Form: TABLET. Route: ORAL

full page →NAPROXEN SODIUM →fda approvals ↗
›Jul 23, 2019approval2597d agoHADLIMA (ADALIMUMAB-BWWD) — FDA approvalHADLIMA

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

full page →HADLIMA →fda approvals ↗
›Jul 24, 2019approval2596d agoAUBAGIO (TERIFLUNOMIDE) — FDA approvalteriflunomide

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

full page →teriflunomide →fda approvals ↗
›Jul 25, 2019approval2595d agoXELJANZ XR (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

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

full page →tofacitinib citrate ER →fda approvals ↗
›Jul 25, 2019approval2595d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

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

full page →fda approvals ↗
›Jul 25, 2019approval2595d agoVENCLEXTA (VENETOCLAX) — FDA approvalvenetoclax

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →venetoclax →fda approvals ↗
›Jul 25, 2019approval2595d agoVENCLEXTA (VENETOCLAX) — FDA approvalvenetoclax

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →venetoclax →fda approvals ↗
›Jul 25, 2019approval2595d agoVENCLEXTA (VENETOCLAX) — FDA approvalvenetoclax

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →venetoclax →fda approvals ↗
›Jul 25, 2019approval2595d agoACCRUFER (FERRIC MALTOL) — FDA approvalferric maltol

Sponsor: SHIELD TX. Form: CAPSULE. Route: ORAL

full page →ferric maltol →fda approvals ↗

Week of Jul 29, 2019

7
›Jul 30, 2019approval2590d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗
›Jul 30, 2019approval2590d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗
›Jul 30, 2019approval2590d agoVECURONIUM BROMIDE — FDA approvalVECURONIUM BROMIDE

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →VECURONIUM BROMIDE →fda approvals ↗
›Jul 31, 2019approval2589d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

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

full page →VIGABATRIN →fda approvals ↗
›Jul 31, 2019approval2589d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

Sponsor: LUNDBECK PHARMS LLC. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗
›Jul 31, 2019approval2589d agoSTIVARGA (REGORAFENIB) — FDA approvalBayer AG

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

full page →fda approvals ↗
›Aug 2, 2019approval2587d agoIDARUBICIN HYDROCHLORIDE — FDA approvalIDARUBICIN HYDROCHLORIDE

Sponsor: PFIZER. Form: SOLUTION. Route: INTRAVENOUS

full page →IDARUBICIN HYDROCHLORIDE →fda approvals ↗

Week of Aug 5, 2019

8
›Aug 5, 2019approval2584d agoVALPROIC ACID — FDA approvalCereno Scientific AB

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

full page →fda approvals ↗
›Aug 5, 2019approval2584d agoAMPHETAMINE SULFATE — FDA approvalamfetamine ER

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →amfetamine ER →fda approvals ↗
›Aug 7, 2019approval2582d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

Sponsor: BAYER. Form: TABLET. Route: ORAL

full page →NAPROXEN SODIUM →fda approvals ↗
›Aug 7, 2019approval2582d agoCELECOXIB — FDA approvalScilex Holding Co

Sponsor: QINGDAO BAHEAL PHARM. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Aug 7, 2019approval2582d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗
›Aug 7, 2019approval2582d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗
›Aug 8, 2019approval2581d agoXULTOPHY 100/3.6 (INSULIN DEGLUDEC) — FDA approvalNovo Nordisk Inc

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗
›Aug 9, 2019approval2580d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: UNICHEM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Week of Aug 12, 2019

12
›Aug 12, 2019approval2577d agoDOXIL (LIPOSOMAL) (DOXORUBICIN HYDROCHLORIDE) — FDA approvalDoxil

Sponsor: BAXTER HLTHCARE CORP. Form: INJECTABLE, LIPOSOMAL. Route: INJECTION

full page →Doxil →fda approvals ↗
›Aug 14, 2019approval2575d agoBOSULIF (BOSUTINIB MONOHYDRATE) — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗
›Aug 14, 2019approval2575d agoWAKIX (PITOLISANT HYDROCHLORIDE) — FDA approvalpitolisant hydrochloride

Sponsor: HARMONY. Form: TABLET. Route: ORAL

full page →pitolisant hydrochloride →fda approvals ↗
›Aug 14, 2019approval2575d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗
›Aug 14, 2019approval2575d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗
›Aug 14, 2019approval2575d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗
›Aug 14, 2019approval2575d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗
›Aug 15, 2019approval2574d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗
›Aug 16, 2019approval2573d agoINREBIC (FEDRATINIB HYDROCHLORIDE) — FDA approvalfedratinib

Sponsor: BRISTOL-MYERS. Form: CAPSULE. Route: ORAL

full page →fedratinib →fda approvals ↗
›Aug 16, 2019approval2573d agoFOSAMAX (ALENDRONATE SODIUM) — FDA approvalALENDRONATE SODIUM

Sponsor: ORGANON. Form: TABLET. Route: ORAL

full page →ALENDRONATE SODIUM →fda approvals ↗
›Aug 16, 2019approval2573d agoFOSAMAX PLUS D (ALENDRONATE SODIUM) — FDA approval(alendronate sodium + cholecalciferol)

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

full page →(alendronate sodium + cholecalciferol) →fda approvals ↗
›Aug 16, 2019approval2573d agoRINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

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

full page →upadacitinib tartrate ER →fda approvals ↗

Week of Aug 19, 2019

4
›Aug 19, 2019approval2570d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →ALENDRONATE SODIUM →fda approvals ↗
›Aug 19, 2019approval2570d agoFULVESTRANT — FDA approvalFULVESTRANT

Sponsor: AVYXA HOLDINGS. Form: SOLUTION. Route: INTRAMUSCULAR

full page →FULVESTRANT →fda approvals ↗
›Aug 23, 2019approval2566d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗
›Aug 23, 2019approval2566d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

Sponsor: ACTAVIS LABS FL INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Week of Aug 26, 2019

1
›Aug 26, 2019approval2563d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
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$CPIX6.6900-20.92%
$AZN162.70-1.11%
$AZN162.70-1.11%
$BLNC
$ABBV256.42+0.37%
$ANIP73.25+0.58%
$PFE28.46+1.79%
$ABBV256.42+0.37%
$PFE28.46+1.79%
$ABBV256.42+0.37%
$OGN13.760.00%
$OGN13.760.00%
$BMY66.81+0.35%
$HRMY39.21-1.66%
$SCLX8.8000+25.00%
$ABBV256.42+0.37%