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calendar

25,528 catalysts · 16,909 approval · 3,564 device 510k · 2,327 grant · 1,050 device pma · 928 device recall · 750 recall

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  • approval16,909
  • device 510k3,564
  • grant2,327
  • device pma1,050
  • device recall928
  • recall750
therapy area

no tagged catalysts yet

Week of Jan 22, 2024

7
›Jan 24, 2024approval952d agoKOSELUGO (SELUMETINIB SULFATE) — FDA approvalselumetinib sulfate

Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL

full page →selumetinib sulfate →fda approvals ↗
›Jan 25, 2024approval951d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

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

full page →dupilumab →fda approvals ↗
›Jan 25, 2024approval951d agoSKYCLARYS (OMAVELOXOLONE) — FDA approvalReata Pharmaceuticals Inc

Sponsor: BIOGEN US. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Jan 25, 2024approval951d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗
›Jan 26, 2024approval950d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗
›Jan 26, 2024approval950d agoELUCIREM (GADOPICLENOL) — FDA approval

Sponsor: GUERBET. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗
›Jan 26, 2024approval950d agoGADAVIST (GADOBUTROL) — FDA approval

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

full page →fda approvals ↗

Week of Jan 29, 2024

9
›Jan 29, 2024approval947d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →carbamazepine ER →fda approvals ↗
›Jan 29, 2024approval947d agoISOTRETINOIN — FDA approvalISOTRETINOIN

Sponsor: AUROBINDO PHARMA. Form: CAPSULE. Route: ORAL

full page →ISOTRETINOIN →fda approvals ↗
›Jan 30, 2024approval946d agoEOVIST (GADOXETATE DISODIUM) — FDA approval

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

full page →fda approvals ↗
›Jan 30, 2024approval946d agoLYBALVI (OLANZAPINE) — FDA approval(olanzapine + samidorphan l-malate)

Sponsor: ALKERMES INC. Form: TABLET. Route: ORAL

full page →(olanzapine + samidorphan l-malate) →fda approvals ↗
›Jan 31, 2024approval945d agoONDANSETRON — FDA approvalondansetron ODT

Sponsor: AUROBINDO PHARMA. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →ondansetron ODT →fda approvals ↗
›Jan 31, 2024approval945d agoONDANSETRON — FDA approvalondansetron ODT

Sponsor: AUROBINDO PHARMA. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →ondansetron ODT →fda approvals ↗
›Feb 1, 2024approval944d agoTRAMADOL HYDROCHLORIDE — FDA approvalGraviti Pharmaceuticals Inc

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

full page →fda approvals ↗
›Feb 1, 2024approval944d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗
›Feb 1, 2024approval944d agoSERTRALINE HYDROCHLORIDE — FDA approvalSERTRALINE HYDROCHLORIDE

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

full page →SERTRALINE HYDROCHLORIDE →fda approvals ↗

Week of Feb 5, 2024

22
›Feb 5, 2024approval940d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗
›Feb 5, 2024approval940d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗
›Feb 5, 2024approval940d agoALLOPURINOL — FDA approvalMylan Pharmaceuticals Inc

Sponsor: REGCON HOLDINGS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Feb 5, 2024approval940d agoALLOPURINOL — FDA approvalMylan Pharmaceuticals Inc

Sponsor: REGCON HOLDINGS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Feb 6, 2024approval939d 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 ↗
›Feb 6, 2024approval939d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗
›Feb 7, 2024approval938d agoFOLLISTIM AQ (FOLLITROPIN ALFA/BETA) — FDA approvalfollitropin beta

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

full page →follitropin beta →fda approvals ↗
›Feb 8, 2024approval937d agoDULOXETINE HYDROCHLORIDE — FDA approvalduloxetine hydrochloride DR

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

full page →duloxetine hydrochloride DR →fda approvals ↗
›Feb 8, 2024approval937d agoDULOXETINE HYDROCHLORIDE — FDA approvalduloxetine hydrochloride DR

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

full page →duloxetine hydrochloride DR →fda approvals ↗
›Feb 8, 2024approval937d agoDULOXETINE HYDROCHLORIDE — FDA approvalduloxetine hydrochloride DR

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

full page →duloxetine hydrochloride DR →fda approvals ↗
›Feb 8, 2024approval937d agoDULOXETINE HYDROCHLORIDE — FDA approvalduloxetine hydrochloride DR

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

full page →duloxetine hydrochloride DR →fda approvals ↗
›Feb 8, 2024approval937d agoDULOXETINE HYDROCHLORIDE — FDA approvalduloxetine hydrochloride DR

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

full page →duloxetine hydrochloride DR →fda approvals ↗
›Feb 8, 2024approval937d agoDULOXETINE HYDROCHLORIDE — FDA approvalduloxetine hydrochloride DR

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

full page →duloxetine hydrochloride DR →fda approvals ↗
›Feb 8, 2024approval937d agoDULOXETINE HYDROCHLORIDE — FDA approvalduloxetine hydrochloride DR

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

full page →duloxetine hydrochloride DR →fda approvals ↗
›Feb 8, 2024approval937d agoDULOXETINE HYDROCHLORIDE — FDA approvalduloxetine hydrochloride DR

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

full page →duloxetine hydrochloride DR →fda approvals ↗
›Feb 8, 2024approval937d agoDULOXETINE HYDROCHLORIDE — FDA approvalduloxetine hydrochloride DR

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

full page →duloxetine hydrochloride DR →fda approvals ↗
›Feb 8, 2024approval937d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: ACTELION. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Feb 8, 2024approval937d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: ACTELION. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Feb 8, 2024approval937d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: PAI HOLDINGS. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗
›Feb 8, 2024approval937d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: PAI HOLDINGS. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗
›Feb 8, 2024approval937d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

full page →blinatumomab →fda approvals ↗
›Feb 8, 2024approval937d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

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

full page →fda approvals ↗

Week of Feb 12, 2024

12
›Feb 12, 2024approval933d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalNovitium Pharma LLC

Sponsor: LGM PHARMA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Feb 12, 2024approval933d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalNovitium Pharma LLC

Sponsor: LGM PHARMA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Feb 12, 2024approval933d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalNovitium Pharma LLC

Sponsor: LGM PHARMA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Feb 12, 2024approval933d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalNovitium Pharma LLC

Sponsor: LGM PHARMA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Feb 12, 2024approval933d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗
›Feb 14, 2024approval931d agoVORICONAZOLE — FDA approvalGreenstone LLC

Sponsor: NOVEL LABS INC. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Feb 14, 2024approval931d agoVORICONAZOLE — FDA approvalGreenstone LLC

Sponsor: NOVEL LABS INC. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Feb 14, 2024approval931d agoVORICONAZOLE — FDA approvalGreenstone LLC

Sponsor: NOVEL LABS INC. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Feb 14, 2024approval931d agoVORICONAZOLE — FDA approvalGreenstone LLC

Sponsor: NOVEL LABS INC. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Feb 14, 2024approval931d agoVORICONAZOLE — FDA approvalGreenstone LLC

Sponsor: NOVEL LABS INC. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Feb 15, 2024approval930d agoENJUVIA (ESTROGENS, CONJUGATED SYNTHETIC B) — FDA approvalENJUVIA

Sponsor: ASPEN. Form: TABLET. Route: ORAL

full page →ENJUVIA →fda approvals ↗
›Feb 15, 2024approval930d agoPROMETRIUM (PROGESTERONE) — FDA approvalIBSA Institut Biochimique SA

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

full page →fda approvals ↗
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$AZN162.47+0.21%
$IGC0.2670+0.41%
$IGC0.2670+0.41%
$IGC0.2670+0.41%
$REGN820.40+2.67%
$BMY66.89+0.13%
$ALKS47.20+0.45%
$IGC0.2670+0.41%
$AMGN436.81+1.61%
$ASPU0.2893-0.26%