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calendar

30,864 catalysts · 18,370 approval · 4,524 device 510k · 3,360 grant · 1,902 device recall · 1,703 device pma · 1,005 recall

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approval18,370
device 510k4,524
grant3,360
device recall1,902
device pma1,703
recall1,005
earnings2

therapy area

no tagged catalysts yet

Week of Sep 18, 2023

›Sep 22, 2023approval1076d agoCARBAMAZEPINE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

›Sep 22, 2023approval1076d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

›Sep 22, 2023approval1076d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Week of Sep 25, 2023

›Sep 25, 2023approval1073d agoLYBALVI (OLANZAPINE) — FDA approval(olanzapine + samidorphan l-malate)

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

full page →(olanzapine + samidorphan l-malate) →fda approvals ↗

›Sep 26, 2023approval

Week of Oct 2, 2023

›Oct 2, 2023approval1066d agoYUFLYMA (ADALIMUMAB-AATY) — FDA approvalYUFLYMA

Sponsor: CELLTRION. Form: INJECTABLE. Route: INJECTION

full page →YUFLYMA →fda approvals ↗

›Oct 3, 2023approval

Week of Oct 9, 2023

›Oct 10, 2023approval1058d agoBUPROPION HYDROCHLORIDE — FDA approvalSenores Pharmaceuticals Inc

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

full page →fda approvals ↗

›Oct 10, 2023approval

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page 281 of 618

1072d ago

BOSULIF (BOSUTINIB MONOHYDRATE) — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗

›Sep 26, 2023approval1072d agoBOSULIF (BOSUTINIB MONOHYDRATE) — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗

›Sep 27, 2023approval1071d agoENTYVIO (VEDOLIZUMAB) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

›Sep 27, 2023approval1071d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

›Sep 28, 2023approval1070d agoSOLIQUA 100/33 (INSULIN GLARGINE) — FDA approvalToujeo LA

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

full page →Toujeo LA →fda approvals ↗

›Sep 28, 2023approval1070d agoADLYXIN (LIXISENATIDE) — FDA approvalADLYXIN

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

full page →ADLYXIN →fda approvals ↗

›Sep 28, 2023approval1070d agoSANDIMMUNE (CYCLOSPORINE) — FDA approvalRestasis

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →Restasis →fda approvals ↗

›Sep 28, 2023approval1070d agoSANDIMMUNE (CYCLOSPORINE) — FDA approvalRestasis

Sponsor: NOVARTIS. Form: INJECTABLE. Route: INJECTION

full page →Restasis →fda approvals ↗

›Sep 28, 2023approval1070d agoSANDIMMUNE (CYCLOSPORINE) — FDA approvalRestasis

Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

full page →Restasis →fda approvals ↗

›Sep 28, 2023approval1070d agoENTYVIO (VEDOLIZUMAB) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Sep 29, 2023approval1069d agoESOMEPRAZOLE MAGNESIUM — FDA approvalesomeprazole magnesium DR

Sponsor: MARKSANS PHARMA. Form: CAPSULE, DELAYED RELEASE. Route: ORAL

full page →esomeprazole magnesium DR →fda approvals ↗

›Sep 29, 2023approval1069d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

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

full page →dupilumab →fda approvals ↗

›Sep 29, 2023approval1069d agoIMPLANON (ETONOGESTREL) — FDA approvaletonogestrel CR

Sponsor: ORGANON. Form: IMPLANT. Route: IMPLANTATION

full page →etonogestrel CR →fda approvals ↗

›Sep 29, 2023approval1069d agoIMPLANON (ETONOGESTREL) — FDA approvaletonogestrel CR

Sponsor: ORGANON. Form: IMPLANT. Route: IMPLANTATION

full page →etonogestrel CR →fda approvals ↗

›Sep 29, 2023approval1069d agoIMPLANON (ETONOGESTREL) — FDA approvaletonogestrel CR

Sponsor: ORGANON. Form: IMPLANT. Route: IMPLANTATION

full page →etonogestrel CR →fda approvals ↗

›Sep 29, 2023approval1069d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Sep 29, 2023approval1069d agoNIZORAL ANTI-DANDRUFF (KETOCONAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: KRAMER. Form: SHAMPOO. Route: TOPICAL

full page →fda approvals ↗

›Sep 29, 2023approval1069d agoSTIMUFEND (PEGFILGRASTIM-FPGK) — FDA approvalSTIMUFEND

Sponsor: FRESENIUS KABI USA. Form: SOLUTION. Route: INJECTION

full page →STIMUFEND →fda approvals ↗

›Sep 29, 2023approval1069d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

1065d ago

BYOOVIZ (RANIBIZUMAB-NUNA) — FDA approvalBYOOVIZ

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

full page →BYOOVIZ →fda approvals ↗

›Oct 3, 2023approval1065d agoEVRYSDI (RISDIPLAM) — FDA approvalEVRYSDI

Sponsor: GENENTECH INC. Form: FOR SOLUTION. Route: ORAL

full page →EVRYSDI →fda approvals ↗

›Oct 3, 2023approval1065d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Oct 3, 2023approval1065d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Oct 3, 2023approval1065d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Oct 4, 2023approval1064d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL

full page →ondansetron hydrochloride CR →fda approvals ↗

›Oct 4, 2023approval1064d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL

full page →ondansetron hydrochloride CR →fda approvals ↗

›Oct 4, 2023approval1064d agoABRILADA (ADALIMUMAB-AFZB) — FDA approvalABRILADA

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

full page →ABRILADA →fda approvals ↗

›Oct 5, 2023approval1063d agoPANTOPRAZOLE SODIUM — FDA approvalPANTOPRAZOLE SODIUM

Sponsor: ASPIRO. Form: INJECTABLE. Route: INTRAVENOUS

full page →PANTOPRAZOLE SODIUM →fda approvals ↗

›Oct 5, 2023approval1063d agoZORYVE (ROFLUMILAST) — FDA approvalArcutis Biotherapeutics, Inc.

Sponsor: ARCUTIS. Form: CREAM. Route: TOPICAL

full page →fda approvals ↗

›Oct 6, 2023approval1062d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Oct 6, 2023approval1062d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Oct 6, 2023approval1062d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: RUBICON RESEARCH. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

›Oct 6, 2023approval1062d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: RUBICON RESEARCH. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

›Oct 6, 2023approval1062d agoDIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

Sponsor: SUN PHARM INDS. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →fda approvals ↗

›Oct 6, 2023approval1062d agoDIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

Sponsor: SUN PHARM INDS. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →fda approvals ↗

›Oct 6, 2023approval1062d agoDIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

Sponsor: SUN PHARM INDS. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →fda approvals ↗

1058d ago

BUPROPION HYDROCHLORIDE — FDA approvalSenores Pharmaceuticals Inc

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

full page →fda approvals ↗

›Oct 10, 2023approval1058d agoBUPROPION HYDROCHLORIDE — FDA approvalSenores Pharmaceuticals Inc

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

full page →fda approvals ↗

›Oct 10, 2023approval1058d agoBUPROPION HYDROCHLORIDE — FDA approvalSenores Pharmaceuticals Inc

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

full page →fda approvals ↗

›Oct 10, 2023approval1058d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Oct 11, 2023approval1057d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

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

full page →fda approvals ↗

›Oct 11, 2023approval1057d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

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

full page →fda approvals ↗

›Oct 11, 2023approval1057d agoBRAFTOVI (ENCORAFENIB) — FDA approvalencorafenib

Sponsor: ARRAY BIOPHARMA INC. Form: CAPSULE. Route: ORAL

full page →encorafenib →fda approvals ↗

›Oct 11, 2023approval1057d agoIDACIO (ADALIMUMAB-AACF) — FDA approvalIDACIO

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →IDACIO →fda approvals ↗

$AMRX17.68+1.20%

$NVS161.00+5.88%

$ALKS47.20+0.45%

$NVS161.00+5.88%

$OGN13.78+0.15%

$RDY12.16+0.29%

$REGN820.40+2.67%

$NVS161.00+5.88%

$OGN13.78+0.15%

$ARQT23.91-0.27%

$OGN13.78+0.15%

$NVS161.00+5.88%

$PFE28.53+0.25%

$AVBP30.15+0.33%

$NVS161.00+5.88%