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29,284 catalysts · 18,062 approval · 4,312 device 510k · 2,691 grant · 1,782 device recall · 1,482 device pma · 955 recall

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  • approval18,062
  • device 510k4,312
  • grant2,691
  • device recall1,782
  • device pma1,482
  • recall955
therapy area

no tagged catalysts yet

Week of Sep 13, 2021

5
›Sep 13, 2021approval1814d agoMETHADOSE (METHADONE HYDROCHLORIDE) — FDA approvalMETHADONE HYDROCHLORIDE

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

full page →METHADONE HYDROCHLORIDE →fda approvals ↗
›Sep 15, 2021approval1812d agoDALFAMPRIDINE — FDA approvalSolaxa Inc

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

full page →fda approvals ↗
›Sep 15, 2021approval1812d agoDALFAMPRIDINE — FDA approvalSolaxa Inc

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

full page →fda approvals ↗
›Sep 17, 2021approval1810d agoBYOOVIZ (RANIBIZUMAB-NUNA) — FDA approvalBYOOVIZ

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

full page →BYOOVIZ →fda approvals ↗
›Sep 17, 2021approval1810d agoCABOMETYX (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

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

full page →cabozantinib s-malate →fda approvals ↗

Week of Sep 20, 2021

9
›Sep 20, 2021approval1807d agoFLUOXETINE HYDROCHLORIDE — FDA approvalFLUOXETINE HYDROCHLORIDE

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

full page →FLUOXETINE HYDROCHLORIDE →fda approvals ↗
›Sep 20, 2021approval1807d agoTIVDAK (TISOTUMAB VEDOTIN-TFTV) — FDA approvaltisotumab vedotin

Sponsor: SEAGEN. Form: INJECTABLE. Route: INJECTION

full page →tisotumab vedotin →fda approvals ↗
›Sep 21, 2021approval1806d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Sep 21, 2021approval1806d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: SUN PHARMA CANADA. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗
›Sep 22, 2021approval1805d agoSUBLOCADE (BUPRENORPHINE) — FDA approvalbuprenorphine LA

Sponsor: INDIVIOR. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS

full page →buprenorphine LA →fda approvals ↗
›Sep 22, 2021approval1805d agoVINCRISTINE SULFATE PFS (VINCRISTINE SULFATE) — FDA approvalVINCRISTINE SULFATE PFS

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →VINCRISTINE SULFATE PFS →fda approvals ↗
›Sep 22, 2021approval1805d agoCOPIKTRA (DUVELISIB) — FDA approvalSecura Bio Inc

Sponsor: SECURA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Sep 23, 2021approval1804d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: DEXCEL. Form: TABLET. Route: ORAL

full page →VIGABATRIN →fda approvals ↗
›Sep 24, 2021approval1803d agoVYEPTI (EPTINEZUMAB-JJMR) — FDA approvalH. Lundbeck AS

Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Week of Sep 27, 2021

11
›Sep 27, 2021approval1800d agoHYCODAN (HOMATROPINE METHYLBROMIDE) — FDA approval

Sponsor: GENUS. Form: SYRUP. Route: ORAL

full page →fda approvals ↗
›Sep 28, 2021approval1799d agoQULIPTA (ATOGEPANT) — FDA approvalatogepant

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →atogepant →fda approvals ↗
›Sep 29, 2021approval1798d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: AUROBINDO PHARMA LTD. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗
›Sep 29, 2021approval1798d agoADDYI (FLIBANSERIN) — FDA approvalSprout2 Inc

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

full page →fda approvals ↗
›Sep 30, 2021approval1797d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION

full page →dulaglutide →fda approvals ↗
›Sep 30, 2021approval1797d agoRUBRACA (RUCAPARIB CAMSYLATE) — FDA approvalrucaparib camsylate

Sponsor: PHARMAAND. Form: TABLET. Route: ORAL

full page →rucaparib camsylate →fda approvals ↗
›Oct 1, 2021approval1796d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

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

full page →dupilumab →fda approvals ↗
›Oct 1, 2021approval1796d agoSOGROYA (SOMAPACITAN-BECO) — FDA approvalsomatriptan albumin bound LA

Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →somatriptan albumin bound LA →fda approvals ↗
›Oct 1, 2021approval1796d agoSOGROYA (SOMAPACITAN-BECO) — FDA approvalsomatriptan albumin bound LA

Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →somatriptan albumin bound LA →fda approvals ↗
›Oct 1, 2021approval1796d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalondansetron hydrochloride CR

Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INJECTION

full page →ondansetron hydrochloride CR →fda approvals ↗
›Oct 1, 2021approval1796d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalondansetron hydrochloride CR

Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INJECTION

full page →ondansetron hydrochloride CR →fda approvals ↗

Week of Oct 4, 2021

15
›Oct 4, 2021approval1793d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

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

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗
›Oct 4, 2021approval1793d agoVENCLEXTA (VENETOCLAX) — FDA approvalvenetoclax

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →venetoclax →fda approvals ↗
›Oct 6, 2021approval1791d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

full page →atezolizumab →fda approvals ↗
›Oct 8, 2021approval1789d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: ACTAVIS LABS FL. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Oct 8, 2021approval1789d agoMYORISAN (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Oct 8, 2021approval1789d agoCLARAVIS (ISOTRETINOIN) — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Oct 8, 2021approval1789d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Oct 8, 2021approval1789d agoABSORICA (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

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

full page →fda approvals ↗
›Oct 8, 2021approval1789d agoAMNESTEEM (ISOTRETINOIN) — FDA approvalMylan Pharmaceuticals Inc

Sponsor: MYLAN PHARMS INC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Oct 8, 2021approval1789d agoCLARAVIS (ISOTRETINOIN) — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Oct 8, 2021approval1789d agoABSORICA LD (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

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

full page →fda approvals ↗
›Oct 8, 2021approval1789d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Oct 8, 2021approval1789d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

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

full page →fda approvals ↗
›Oct 8, 2021approval1789d agoZENATANE (ISOTRETINOIN) — FDA approvalISOTRETINOIN

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

full page →ISOTRETINOIN →fda approvals ↗
›Oct 8, 2021approval1789d agoALVIMOPAN — FDA approvalPar Pharmaceutical Inc

Sponsor: WATSON LABS TEVA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Week of Oct 11, 2021

8
›Oct 13, 2021approval1784d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗
›Oct 13, 2021approval1784d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗
›Oct 13, 2021approval1784d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

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

full page →fda approvals ↗
›Oct 13, 2021approval1784d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗
›Oct 13, 2021approval1784d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Oct 15, 2021approval1782d agoARSENIC TRIOXIDE — FDA approvalQuetzal Therapeutics LLC

Sponsor: EUGIA PHARMA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Oct 15, 2021approval1782d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

full page →atezolizumab →fda approvals ↗
›Oct 15, 2021approval1782d agoCYLTEZO (ADALIMUMAB-ADBM) — FDA approvalCYLTEZO

Sponsor: BOEHRINGER INGELHEIM. Form: INJECTABLE. Route: INJECTION

full page →CYLTEZO →fda approvals ↗

Week of Oct 18, 2021

2
›Oct 20, 2021approval1777d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

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

full page →dupilumab →fda approvals ↗
›Oct 20, 2021approval1777d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

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

full page →VIGABATRIN →fda approvals ↗
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$VERX14.16-0.46%
$REGN799.08+0.62%
$INDV34.93+0.17%
$ABBV256.42+0.37%
$LLY1157.39-1.47%
$NVO45.41-0.43%
$REGN799.08+0.62%
$EXEL54.64+0.35%
$ABBV256.42+0.37%
$RDY12.13-0.41%
$ABBV256.42+0.37%
$NVO45.41-0.43%