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calendar

25,822 catalysts · 16,936 approval · 3,617 device 510k · 2,351 grant · 1,087 device recall · 1,069 device pma · 762 recall

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  • approval16,936
  • device 510k3,617
  • grant2,351
  • device recall1,087
  • device pma1,069
  • recall762
therapy area

no tagged catalysts yet

Week of Jul 24, 2023

12
›Jul 26, 2023approval1134d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

Sponsor: HIKMA INTL PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Jul 26, 2023approval1134d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

Sponsor: HIKMA INTL PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Jul 26, 2023approval1134d agoSERTRALINE HYDROCHLORIDE — FDA approvalSERTRALINE HYDROCHLORIDE

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

full page →SERTRALINE HYDROCHLORIDE →fda approvals ↗
›Jul 26, 2023approval1134d agoSERTRALINE HYDROCHLORIDE — FDA approvalSERTRALINE HYDROCHLORIDE

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

full page →SERTRALINE HYDROCHLORIDE →fda approvals ↗
›Jul 26, 2023approval1134d agoTIVDAK (TISOTUMAB VEDOTIN-TFTV) — FDA approvaltisotumab vedotin

Sponsor: SEAGEN. Form: INJECTABLE. Route: INJECTION

full page →tisotumab vedotin →fda approvals ↗
›Jul 26, 2023approval1134d agoHIBICLENS (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

Sponsor: MOLNLYCKE HLTH. Form: SOLUTION. Route: TOPICAL

full page →fda approvals ↗
›Jul 28, 2023approval1132d agoCINACALCET HYDROCHLORIDE — FDA approvalCINACALCET HYDROCHLORIDE

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

full page →CINACALCET HYDROCHLORIDE →fda approvals ↗
›Jul 28, 2023approval1132d agoZEPZELCA (LURBINECTEDIN) — FDA approvallurbinectedin

Sponsor: JAZZ. Form: POWDER. Route: INTRAVENOUS

full page →lurbinectedin →fda approvals ↗
›Jul 28, 2023approval1132d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗
›Jul 28, 2023approval1132d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗
›Jul 28, 2023approval1132d agoMOUNJARO (TIRZEPATIDE) — FDA approvalZEPBOUND

Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ZEPBOUND →fda approvals ↗
›Jul 28, 2023approval1132d agoMOUNJARO (TIRZEPATIDE) — FDA approvalZEPBOUND

Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ZEPBOUND →fda approvals ↗

Week of Jul 31, 2023

10
›Jul 31, 2023approval1129d agoARTESUNATE — FDA approvalARTESUNATE

Sponsor: AMIVAS. Form: POWDER. Route: INTRAVENOUS

full page →ARTESUNATE →fda approvals ↗
›Jul 31, 2023approval1129d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗
›Aug 3, 2023approval1126d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

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

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗
›Aug 3, 2023approval1126d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

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

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗
›Aug 3, 2023approval1126d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

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

full page →(ivacaftor + lumacaftor) →fda approvals ↗
›Aug 3, 2023approval1126d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

full page →fda approvals ↗
›Aug 3, 2023approval1126d agoKALYDECO (IVACAFTOR) — FDA approvalivacaftor

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

full page →ivacaftor →fda approvals ↗
›Aug 3, 2023approval1126d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

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

full page →(ivacaftor + lumacaftor) →fda approvals ↗
›Aug 3, 2023approval1126d agoSYMDEKO (COPACKAGED) (IVACAFTOR) — FDA approvalivacaftor

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

full page →ivacaftor →fda approvals ↗
›Aug 4, 2023approval1125d agoIZERVAY (AVACINCAPTAD PEGOL SODIUM) — FDA approvalavacincaptad pegol sodium

Sponsor: ASTELLAS. Form: SOLUTION. Route: INTRAVITREAL

full page →avacincaptad pegol sodium →fda approvals ↗

Week of Aug 7, 2023

8
›Aug 8, 2023approval1121d agoVORICONAZOLE — FDA approvalVORICONAZOLE

Sponsor: CADILA. Form: TABLET. Route: ORAL

full page →VORICONAZOLE →fda approvals ↗
›Aug 8, 2023approval1121d agoVORICONAZOLE — FDA approvalVORICONAZOLE

Sponsor: CADILA. Form: TABLET. Route: ORAL

full page →VORICONAZOLE →fda approvals ↗
›Aug 8, 2023approval1121d agoZIPRASIDONE MESYLATE — FDA approvalZIPRASIDONE MESYLATE

Sponsor: GLAND. Form: POWDER. Route: INTRAMUSCULAR

full page →ZIPRASIDONE MESYLATE →fda approvals ↗
›Aug 9, 2023approval1120d agoACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

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

full page →ACETAZOLAMIDE →fda approvals ↗
›Aug 9, 2023approval1120d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

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

full page →teclistamab →fda approvals ↗
›Aug 9, 2023approval1120d agoTALVEY (TALQUETAMAB-TGVS) — FDA approvaltalquetamab

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

full page →talquetamab →fda approvals ↗
›Aug 9, 2023approval1120d agoGAVRETO (PRALSETINIB) — FDA approvalRIGEL PHARMACEUTICALS INC

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

full page →fda approvals ↗
›Aug 11, 2023approval1118d agoAKEEGA (ABIRATERONE ACETATE) — FDA approval(abiraterone acetate + niraparib)

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

full page →(abiraterone acetate + niraparib) →fda approvals ↗

Week of Aug 14, 2023

15
›Aug 14, 2023approval1115d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗
›Aug 14, 2023approval1115d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗
›Aug 14, 2023approval1115d agoELREXFIO (ELRANATAMAB) — FDA approvalelranatamab

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

full page →elranatamab →fda approvals ↗
›Aug 14, 2023approval1115d agoAMJEVITA (ADALIMUMAB-ATTO) — FDA approvalAMJEVITA

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

full page →AMJEVITA →fda approvals ↗
›Aug 15, 2023approval1114d agoVONJO (PACRITINIB CITRATE) — FDA approvalpacritinib

Sponsor: SOBI. Form: CAPSULE. Route: ORAL

full page →pacritinib →fda approvals ↗
›Aug 16, 2023approval1113d agoABRILADA (ADALIMUMAB-AFZB) — FDA approvalABRILADA

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

full page →ABRILADA →fda approvals ↗
›Aug 16, 2023approval1113d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

Sponsor: SANOFI AVENTIS US. Form: INJECTABLE. Route: INJECTION

full page →RIFADIN →fda approvals ↗
›Aug 16, 2023approval1113d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

full page →RIFATER →fda approvals ↗
›Aug 16, 2023approval1113d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

Sponsor: SANOFI AVENTIS US. Form: CAPSULE. Route: ORAL

full page →RIFADIN →fda approvals ↗
›Aug 16, 2023approval1113d agoACETAZOLAMIDE — FDA approvalAccord Healthcare Inc

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

full page →fda approvals ↗
›Aug 16, 2023approval1113d agoVOQUEZNA TRIPLE PAK (AMOXICILLIN) — FDA approvalamoxicillin + clarithromycin + vonoprazan

Sponsor: PHATHOM. Form: CAPSULE, TABLET, TABLET. Route: ORAL

full page →amoxicillin + clarithromycin + vonoprazan →fda approvals ↗
›Aug 16, 2023approval1113d agoVOQUEZNA DUAL PAK (AMOXICILLIN) — FDA approvalamoxicillin + vonoprazan fumarate

Sponsor: PHATHOM. Form: CAPSULE, TABLET. Route: ORAL

full page →amoxicillin + vonoprazan fumarate →fda approvals ↗
›Aug 17, 2023approval1112d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: INTRAVENOUS

full page →remdesivir →fda approvals ↗
›Aug 18, 2023approval1111d agoEYLEA HD (AFLIBERCEPT) — FDA approvalEYLEA HD

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

full page →EYLEA HD →fda approvals ↗
›Aug 18, 2023approval1111d agoFLUOXETINE HYDROCHLORIDE — FDA approvalFLUOXETINE HYDROCHLORIDE

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

full page →FLUOXETINE HYDROCHLORIDE →fda approvals ↗

Week of Aug 21, 2023

5
›Aug 22, 2023approval1107d agoFOCINVEZ (FOSAPREPITANT DIMEGLUMINE) — FDA approvalAthenex Inc (Inactive)

Sponsor: STERISCIENCE. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗
›Aug 23, 2023approval1106d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

Sponsor: MICRO LABS. Form: TABLET. Route: ORAL

full page →LOSARTAN POTASSIUM →fda approvals ↗
›Aug 23, 2023approval1106d agoCOMETRIQ (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

Sponsor: EXELIXIS. Form: CAPSULE. Route: ORAL

full page →cabozantinib s-malate →fda approvals ↗
›Aug 23, 2023approval1106d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: INTRAVENOUS

full page →remdesivir →fda approvals ↗
›Aug 24, 2023approval1105d agoTYRUKO (NATALIZUMAB-SZTN) — FDA approvalnatalizumab biosimilar

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

full page →natalizumab biosimilar →fda approvals ↗
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$PYPD5.3300+3.70%
$PYPD5.3300+3.70%
$LLY1171.08+1.24%
$LLY1171.08+1.24%
$VERX13.83-2.33%
$JAZZ243.64-2.81%
$VERX13.83-2.33%
$VERX13.83-2.33%
$VERX13.83-2.33%
$VERX13.83-2.33%
$VERX13.83-2.33%
$VERX13.83-2.33%
$RIGL46.68+1.08%
$PFE28.53+0.25%
$AMGN436.81+1.61%
$PFE28.53+0.25%
$PHAT9.3900-1.88%
$PHAT9.3900-1.88%
$REGN820.40+2.67%
$GILD148.94+1.78%
$GILD148.94+1.78%
$EXEL56.89+4.12%