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calendar

24,846 catalysts · 5,282 approval · 5,000 device 510k · 4,728 grant · 3,045 8k filing · 2,000 device pma · 2,000 device recall

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2026-08-10: 75 catalysts2026-08-11: 16 catalysts2026-08-12: 19 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 2 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 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: 0 catalysts2026-10-01: 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: 20 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 8 catalysts2026-11-03: 17 catalysts2026-11-04: 22 catalysts2026-11-05: 36 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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  • approval5,282
  • device 510k5,000
  • grant4,728
  • 8k filing3,045
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings578
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Apr 24, 2023

    6
    ›Apr 28, 2023approval1201d agoVIGABATRIN — FDA approvalVIGABATRIN

    Sponsor: CARNEGIE. Form: TABLET. Route: ORAL

    full page →VIGABATRIN →fda approvals ↗
    ›Apr 28, 2023approval1201d agoSOGROYA (SOMAPACITAN-BECO) — FDA approvalsomatriptan albumin bound LA

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

    full page →somatriptan albumin bound LA →fda approvals ↗
    ›Apr 28, 2023approval1201d agoLIBTAYO (CEMIPLIMAB-RWLC) — FDA approvalcemiplimab

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

    full page →cemiplimab →fda approvals ↗
    ›Apr 28, 2023approval1201d agoLIBTAYO (CEMIPLIMAB-RWLC) — FDA approvalcemiplimab

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

    full page →cemiplimab →fda approvals ↗
    ›Apr 28, 2023approval1201d agoUZEDY (RISPERIDONE) — FDA approvalDelpor Inc

    Sponsor: TEVA. Form: SUSPENSION, EXTENDED RELEASE. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Apr 28, 2023approval1201d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

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

    full page →remdesivir →fda approvals ↗

    Week of May 1, 2023

    11
    ›May 1, 2023approval1198d agoDALFAMPRIDINE — FDA approvaldalfampridine ER

    Sponsor: ACCORD HLTHCARE. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →dalfampridine ER →fda approvals ↗
    ›May 1, 2023approval

    Week of May 8, 2023

    12
    ›May 8, 2023approval1191d agoCEFAZOLIN SODIUM — FDA approvalSamson Medical Technologies LLC

    Sponsor: HQ SPCLT PHARMA. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›May 8, 2023approval

    Week of May 15, 2023

    12
    ›May 15, 2023approval1184d agoINREBIC (FEDRATINIB HYDROCHLORIDE) — FDA approvalfedratinib

    Sponsor: BRISTOL-MYERS. Form: CAPSULE. Route: ORAL

    full page →fedratinib →fda approvals ↗
    ›May 18, 2023approval

    Week of May 22, 2023

    9
    ›May 22, 2023approval1177d agoVIGPODER (VIGABATRIN) — FDA approvalPyros Pharmaceuticals Inc.

    Sponsor: PYROS PHARMS. Form: FOR SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›May 22, 2023approval
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    page 1 of 497
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    1198d ago
    ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalDR REDDYS LABORATORIES LTD

    Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›May 1, 2023approval1198d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalDR REDDYS LABORATORIES LTD

    Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›May 1, 2023approval1198d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

    Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›May 1, 2023approval1198d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

    Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›May 1, 2023approval1198d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

    Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›May 1, 2023approval1198d agoDALFAMPRIDINE — FDA approvalSolaxa Inc

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

    full page →fda approvals ↗
    ›May 3, 2023approval1196d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

    full page →fda approvals ↗
    ›May 3, 2023approval1196d agoKALYDECO (IVACAFTOR) — FDA approvalivacaftor

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

    full page →ivacaftor →fda approvals ↗
    ›May 3, 2023approval1196d agoTOPAMAX SPRINKLE (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›May 3, 2023approval1196d agoTOPAMAX (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    1191d ago
    GLATOPA (GLATIRAMER ACETATE) — FDA approvalGLATIRAMER ACETATE

    Sponsor: SANDOZ. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →GLATIRAMER ACETATE →fda approvals ↗
    ›May 8, 2023approval1191d agoBYLVAY (ODEVIXIBAT) — FDA approvalodevixibat

    Sponsor: IPSEN. Form: CAPSULE. Route: ORAL

    full page →odevixibat →fda approvals ↗
    ›May 9, 2023approval1190d 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 ↗
    ›May 9, 2023approval1190d agoELELYSO (TALIGLUCERASE ALFA) — FDA approvaltaliglucerase alfa

    Sponsor: PFIZER. Form: POWDER. Route: INTRAVENOUS

    full page →taliglucerase alfa →fda approvals ↗
    ›May 10, 2023approval1189d agoVERQUVO (VERICIGUAT) — FDA approvalMerck & Co., Inc.

    Sponsor: MSD. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›May 11, 2023approval1188d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

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

    full page →fda approvals ↗
    ›May 11, 2023approval1188d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

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

    full page →ALENDRONATE SODIUM →fda approvals ↗
    ›May 11, 2023approval1188d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

    Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›May 12, 2023approval1187d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

    Sponsor: LAURUS. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›May 12, 2023approval1187d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

    full page →atezolizumab →fda approvals ↗
    ›May 12, 2023approval1187d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

    full page →atezolizumab →fda approvals ↗
    1181d ago
    IMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

    Sponsor: PHARMACYCLICS LLC. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›May 18, 2023approval1181d agoMIEBO (PERFLUOROHEXYLOCTANE) — FDA approvalBausch & Lomb Corp

    Sponsor: BAUSCH AND LOMB INC. Form: SOLUTION/DROPS. Route: OPHTHALMIC

    full page →fda approvals ↗
    ›May 18, 2023approval1181d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

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

    full page →fda approvals ↗
    ›May 18, 2023approval1181d agoCYLTEZO (ADALIMUMAB-ADBM) — FDA approvalCYLTEZO

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

    full page →CYLTEZO →fda approvals ↗
    ›May 18, 2023approval1181d agoRINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

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

    full page →upadacitinib tartrate ER →fda approvals ↗
    ›May 19, 2023approval1180d agoLEVETIRACETAM — FDA approvalAprecia Pharmaceuticals LLC

    Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›May 19, 2023approval1180d agoLEVETIRACETAM — FDA approvalAprecia Pharmaceuticals LLC

    Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›May 19, 2023approval1180d agoLEVETIRACETAM — FDA approvalAprecia Pharmaceuticals LLC

    Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›May 19, 2023approval1180d agoLEVETIRACETAM — FDA approvalAprecia Pharmaceuticals LLC

    Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›May 19, 2023approval1180d agoLEVETIRACETAM — FDA approvalAprecia Pharmaceuticals LLC

    Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›May 19, 2023approval1180d agoEPKINLY (EPCORITAMAB-BYSP) — FDA approvalepcoritamab

    Sponsor: GENMAB US, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →epcoritamab →fda approvals ↗
    1177d ago
    HYDROMORPHONE HYDROCHLORIDE — FDA approvalSpecGx LLC

    Sponsor: PADAGIS US. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›May 23, 2023approval1176d agoHALOPERIDOL DECANOATE — FDA approvalHALOPERIDOL DECANOATE

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

    full page →HALOPERIDOL DECANOATE →fda approvals ↗
    ›May 23, 2023approval1176d agoDIVIGEL (ESTRADIOL) — FDA approvalVertical Pharmaceuticals LLC

    Sponsor: VERTICAL PHARMS. Form: GEL. Route: TRANSDERMAL

    full page →fda approvals ↗
    ›May 23, 2023approval1176d agoBRIXADI (BUPRENORPHINE) — FDA approvalbuprenorphine LA

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

    full page →buprenorphine LA →fda approvals ↗
    ›May 23, 2023approval1176d agoYUFLYMA (ADALIMUMAB-AATY) — FDA approvalYUFLYMA

    Sponsor: CELLTRION. Form: INJECTABLE. Route: INJECTION

    full page →YUFLYMA →fda approvals ↗
    ›May 24, 2023approval1175d agoACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

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

    full page →ACETAZOLAMIDE →fda approvals ↗
    ›May 24, 2023approval1175d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalondansetron hydrochloride CR

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

    full page →ondansetron hydrochloride CR →fda approvals ↗
    ›May 25, 2023approval1174d agoSUSTOL (GRANISETRON) — FDA approvalgranisetron ER

    Sponsor: HERON THERAPS INC. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →granisetron ER →fda approvals ↗
    $REGN808.05+3.02%
    $REGN808.05+3.02%
    $NVO47.73+0.99%
    $BMY64.84+0.19%
    $GILD133.06-0.11%
    $RDHL0.7390+6.64%
    $RDY12.15-0.57%
    $RDY12.15-0.57%
    $RDHL0.7390+6.64%
    $VERX12.13+1.63%
    $VERX12.13+1.63%
    $MRK130.92+1.82%
    $PFE27.05+1.08%
    $NVS156.79+0.29%
    $CPIX7.7900-0.13%
    $HRTX0.5114+3.06%
    $BLCO16.83+0.30%
    $ABBV247.97+0.78%
    $ABBV247.97+0.78%
    $ABBV247.97+0.78%