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calendar

24,139 catalysts · 16,565 approval · 3,298 device 510k · 2,058 grant · 836 device pma · 737 device recall · 645 recall

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2026-08-31: 0 catalysts2026-09-01: 20 catalysts2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 1 catalyst2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts2026-11-09: 1 catalyst2026-11-10: 0 catalysts2026-11-11: 0 catalysts2026-11-12: 0 catalysts2026-11-13: 0 catalysts2026-11-14: 0 catalysts2026-11-15: 0 catalysts2026-11-16: 0 catalysts2026-11-17: 0 catalysts2026-11-18: 0 catalysts2026-11-19: 0 catalysts2026-11-20: 0 catalysts2026-11-21: 0 catalysts2026-11-22: 0 catalysts2026-11-23: 0 catalysts2026-11-24: 0 catalysts2026-11-25: 0 catalysts2026-11-26: 0 catalysts2026-11-27: 0 catalysts2026-11-28: 0 catalysts2026-11-29: 0 catalysts
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  • approval16,565
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  • device pma836
  • device recall737
  • recall645
therapy area

no tagged catalysts yet

Week of Jul 5, 2021

9
›Jul 8, 2021approval1882d agoPOTELIGEO (MOGAMULIZUMAB-KPKC) — FDA approvalmogamulizumab

Sponsor: KYOWA KIRIN. Form: INJECTABLE. Route: INJECTION

full page →mogamulizumab →fda approvals ↗
›Jul 8, 2021approval1882d agoWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

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

full page →fda approvals ↗
›Jul 8, 2021approval1882d agoAPLENZIN (BUPROPION HYDROBROMIDE) — FDA approvalBausch Health US LLC

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

full page →fda approvals ↗
›Jul 9, 2021approval1881d agoDARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ) — FDA approval(daratumumab + hyaluronidase (human recombinant))

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →(daratumumab + hyaluronidase (human recombinant)) →fda approvals ↗
›Jul 9, 2021approval1881d agoPADCEV (ENFORTUMAB VEDOTIN-EJFV) — FDA approvalenfortumab vedotin

Sponsor: ASTELLAS. Form: INJECTABLE. Route: INJECTION

full page →enfortumab vedotin →fda approvals ↗
›Jul 9, 2021approval1881d agoPADCEV (ENFORTUMAB VEDOTIN-EJFV) — FDA approvalenfortumab vedotin

Sponsor: ASTELLAS. Form: INJECTABLE. Route: INJECTION

full page →enfortumab vedotin →fda approvals ↗
›Jul 9, 2021approval1881d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

full page →fda approvals ↗
›Jul 9, 2021approval1881d agoTIVICAY PD (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Jul 9, 2021approval1881d agoJULUCA (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

full page →fda approvals ↗

Week of Jul 12, 2021

9
›Jul 13, 2021approval1877d agoBACLOFEN — FDA approvalBACLOFEN

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

full page →BACLOFEN →fda approvals ↗
›Jul 14, 2021approval1876d agoERLEADA (APALUTAMIDE) — FDA approvalapalutamide

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

full page →apalutamide →fda approvals ↗
›Jul 15, 2021approval1875d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗
›Jul 15, 2021approval1875d agoPREGABALIN — FDA approvalViatris Inc

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

full page →fda approvals ↗
›Jul 15, 2021approval1875d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

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

full page →fda approvals ↗
›Jul 16, 2021approval1874d agoREZUROCK (BELUMOSUDIL MESYLATE) — FDA approvalbelumosudil mesylate

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

full page →belumosudil mesylate →fda approvals ↗
›Jul 16, 2021approval1874d agoVORICONAZOLE — FDA approvalVORICONAZOLE

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

full page →VORICONAZOLE →fda approvals ↗
›Jul 16, 2021approval1874d agoVORICONAZOLE — FDA approvalVORICONAZOLE

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

full page →VORICONAZOLE →fda approvals ↗
›Jul 16, 2021approval1874d agoVORICONAZOLE — FDA approvalVORICONAZOLE

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

full page →VORICONAZOLE →fda approvals ↗

Week of Jul 19, 2021

8
›Jul 20, 2021approval1870d agoBYLVAY (ODEVIXIBAT) — FDA approvalodevixibat

Sponsor: IPSEN. Form: CAPSULE. Route: ORAL

full page →odevixibat →fda approvals ↗
›Jul 21, 2021approval1869d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗
›Jul 21, 2021approval1869d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

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

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Jul 21, 2021approval1869d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: GENUS LIFESCIENCES. Form: CAPSULE. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Jul 21, 2021approval1869d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: GENUS LIFESCIENCES. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗
›Jul 22, 2021approval1868d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →Kapanol →fda approvals ↗
›Jul 23, 2021approval1867d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

full page →nivolumab →fda approvals ↗
›Jul 23, 2021approval1867d agoPREZCOBIX (COBICISTAT) — FDA approvalGILEAD SCIENCES, INC.

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

full page →fda approvals ↗

Week of Jul 26, 2021

16
›Jul 26, 2021approval1864d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗
›Jul 26, 2021approval1864d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗
›Jul 26, 2021approval1864d agoATROPINE SULFATE — FDA approvalATROPINE SULFATE

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

full page →ATROPINE SULFATE →fda approvals ↗
›Jul 28, 2021approval1862d agoSOLIQUA 100/33 (INSULIN GLARGINE) — FDA approvalToujeo LA

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

full page →Toujeo LA →fda approvals ↗
›Jul 29, 2021approval1861d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

full page →fda approvals ↗
›Jul 29, 2021approval1861d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Jul 29, 2021approval1861d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Jul 29, 2021approval1861d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗
›Jul 29, 2021approval1861d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: TABLET, CHEWABLE. Route: ORAL

full page →fda approvals ↗
›Jul 30, 2021approval1860d agoADLYXIN (LIXISENATIDE) — FDA approvalADLYXIN

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

full page →ADLYXIN →fda approvals ↗
›Jul 30, 2021approval1860d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: CSPC OUYI PHARM CO. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Jul 30, 2021approval1860d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: CSPC OUYI PHARM CO. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Jul 30, 2021approval1860d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: CSPC OUYI PHARM CO. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Jul 30, 2021approval1860d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: CSPC OUYI PHARM CO. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Jul 30, 2021approval1860d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: CSPC OUYI PHARM CO. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Jul 30, 2021approval1860d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: CSPC OUYI PHARM CO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Week of Aug 2, 2021

5
›Aug 2, 2021approval1857d agoMETHOTREXATE SODIUM PRESERVATIVE FREE (METHOTREXATE SODIUM) — FDA approvalPFIZER INC

Sponsor: PHARMACHEMIE BV. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Aug 2, 2021approval1857d agoMETHOTREXATE SODIUM PRESERVATIVE FREE (METHOTREXATE SODIUM) — FDA approvalPFIZER INC

Sponsor: PHARMACHEMIE BV. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Aug 2, 2021approval1857d agoORIAHNN (COPACKAGED) (ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE) — FDA approvalORIAHNN (COPACKAGED)

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →ORIAHNN (COPACKAGED) →fda approvals ↗
›Aug 3, 2021approval1856d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗
›Aug 4, 2021approval1855d agoMORPHINE SULFATE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: ANDA REPOSITORY. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Week of Aug 9, 2021

3
›Aug 10, 2021approval1849d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗
›Aug 13, 2021approval1846d agoXeomin (incobotulinumtoxinA) — FDA approvalMerz Pharmaceuticals LLC

Sponsor: MERZ PHARMS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Aug 13, 2021approval1846d agoLEUPROLIDE ACETATE — FDA approvalLEUPROLIDE ACETATE

Sponsor: SOMERSET THERAPS LLC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗
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$PFE28.46+1.79%
$BMY66.81+0.35%
$PFE28.46+1.79%
$BMY66.81+0.35%
$VTRS16.51+1.04%
$GILD146.34+0.45%
$AZN162.13-0.35%
$ABBV256.42+0.37%