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calendar

29,251 catalysts · 18,044 approval · 4,307 device 510k · 2,688 grant · 1,777 device recall · 1,480 device pma · 955 recall

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  • approval18,044
  • device 510k4,307
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  • device recall1,777
  • device pma1,480
  • recall955
therapy area

no tagged catalysts yet

Week of Sep 28, 2020

19
›Sep 29, 2020approval2163d agoRELGAABI (GABAPENTIN) — FDA approvalSciegen Pharmaceuticals Inc

Sponsor: SCIEGEN PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Sep 29, 2020approval2163d agoATROPINE SULFATE — FDA approvalATROPINE SULFATE

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

full page →ATROPINE SULFATE →fda approvals ↗
›Sep 29, 2020approval2163d agoUNITUXIN (DINUTUXIMAB) — FDA approvalUNITED THERAPEUTICS Corp

Sponsor: UNITED THERAP. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗
›Sep 30, 2020approval2162d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →LOSARTAN POTASSIUM →fda approvals ↗
›Sep 30, 2020approval2162d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

full page →atezolizumab →fda approvals ↗
›Oct 2, 2020approval2160d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗
›Oct 2, 2020approval2160d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗
›Oct 2, 2020approval2160d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

Sponsor: PH HEALTH. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗
›Oct 2, 2020approval2160d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

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

full page →VIGABATRIN →fda approvals ↗
›Oct 2, 2020approval2160d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

Sponsor: DR REDDYS. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗
›Oct 2, 2020approval2160d agoVIGABATRIN — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗
›Oct 2, 2020approval2160d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Oct 2, 2020approval2160d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗
›Oct 2, 2020approval2160d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

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

full page →VIGABATRIN →fda approvals ↗
›Oct 2, 2020approval2160d agoVIGADRONE (VIGABATRIN) — FDA approvalVIGABATRIN

Sponsor: AUCTA. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗
›Oct 2, 2020approval2160d agoVIGABATRIN — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: INVAGEN PHARMS. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗
›Oct 2, 2020approval2160d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: GRANULES. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗
›Oct 2, 2020approval2160d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: RISING. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗
›Oct 2, 2020approval2160d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: RISING. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

Week of Oct 5, 2020

14
›Oct 6, 2020approval2156d agoDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ATROPINE SULFATE) — FDA approvalATROPINE SULFATE

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

full page →ATROPINE SULFATE →fda approvals ↗
›Oct 6, 2020approval2156d agoPALYNZIQ (PEGVALIASE-PQPZ) — FDA approvalBIOMARIN PHARMACEUTICAL INC

Sponsor: BIOMARIN PHARM. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Oct 6, 2020approval2156d agoPALYNZIQ (PEGVALIASE-PQPZ) — FDA approvalBIOMARIN PHARMACEUTICAL INC

Sponsor: BIOMARIN PHARM. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Oct 6, 2020approval2156d agoPALYNZIQ (PEGVALIASE-PQPZ) — FDA approvalBIOMARIN PHARMACEUTICAL INC

Sponsor: BIOMARIN PHARM. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Oct 6, 2020approval2156d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

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

full page →fda approvals ↗
›Oct 7, 2020approval2155d agoACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

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

full page →ACETAZOLAMIDE →fda approvals ↗
›Oct 8, 2020approval2154d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Sponsor: QUAGEN. Form: SYRUP. Route: ORAL

full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗
›Oct 8, 2020approval2154d agoRUBRACA (RUCAPARIB CAMSYLATE) — FDA approvalrucaparib camsylate

Sponsor: PHARMAAND. Form: TABLET. Route: ORAL

full page →rucaparib camsylate →fda approvals ↗
›Oct 9, 2020approval2153d agoUNASYN (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗
›Oct 9, 2020approval2153d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗
›Oct 9, 2020approval2153d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗
›Oct 9, 2020approval2153d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗
›Oct 9, 2020approval2153d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗
›Oct 9, 2020approval2153d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

Sponsor: ALEXION PHARM. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Week of Oct 12, 2020

10
›Oct 13, 2020approval2149d agoWAKIX (PITOLISANT HYDROCHLORIDE) — FDA approvalpitolisant hydrochloride

Sponsor: HARMONY. Form: TABLET. Route: ORAL

full page →pitolisant hydrochloride →fda approvals ↗
›Oct 13, 2020approval2149d agoBINOSTO (ALENDRONATE SODIUM) — FDA approvalOrganon & Co.

Sponsor: RADIUS. Form: TABLET, EFFERVESCENT. Route: ORAL

full page →fda approvals ↗
›Oct 14, 2020approval2148d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗
›Oct 14, 2020approval2148d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: LANNETT CO INC. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗
›Oct 14, 2020approval2148d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: LANNETT CO INC. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗
›Oct 14, 2020approval2148d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: LANNETT CO INC. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗
›Oct 14, 2020approval2148d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: LANNETT CO INC. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗
›Oct 14, 2020approval2148d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: LANNETT CO INC. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗
›Oct 16, 2020approval2146d agoVENCLEXTA (VENETOCLAX) — FDA approvalvenetoclax

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →venetoclax →fda approvals ↗
›Oct 16, 2020approval2146d agoVENCLEXTA (VENETOCLAX) — FDA approvalvenetoclax

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →venetoclax →fda approvals ↗

Week of Oct 19, 2020

7
›Oct 19, 2020approval2143d agoQSYMIA (PHENTERMINE HYDROCHLORIDE) — FDA approval(phentermine hydrochloride + topiramate) ER

Sponsor: VIVUS LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →(phentermine hydrochloride + topiramate) ER →fda approvals ↗
›Oct 19, 2020approval2143d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Oct 19, 2020approval2143d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Oct 19, 2020approval2143d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Oct 19, 2020approval2143d agoARIKAYCE KIT (AMIKACIN SULFATE) — FDA approvalamikacin sulfate PR

Sponsor: INSMED INC. Form: SUSPENSION, LIPOSOMAL. Route: INHALATION

full page →amikacin sulfate PR →fda approvals ↗
›Oct 19, 2020approval2143d agoRISPERIDONE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗
›Oct 19, 2020approval2143d agoRISPERIDONE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗
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$HRMY39.21-1.66%
$BMRN65.23+0.87%
$BMRN65.23+0.87%
$COLL25.35-4.12%
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$BMY66.81+0.35%
$OGN13.760.00%
$AMRX17.54-2.61%
$AMRX17.54-2.61%
$AMRX17.54-2.61%
$UTHR511.21-0.82%
$PFE28.46+1.79%
$ABBV256.42+0.37%
$ABBV256.42+0.37%
$INSM121.82+2.77%