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calendar

18,993 catalysts · 18,987 approval · 7,115 phase readout · 5,000 device 510k · 4,728 grant · 3,590 8k filing · 2,000 device pma

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  • approval18,987
  • phase readout7,115
  • device 510k5,000
  • grant4,728
  • 8k filing3,590
  • device pma2,000
  • device recall
2,000
  • recall1,126
  • device adverse event1,000
  • earnings585
  • therapy area
    • Ophthalmology5

    Week of May 26, 2025

    11
    ›May 28, 2025approval458d agoSOLIQUA 100/33 (INSULIN GLARGINE) — FDA approvalToujeo LA

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

    full page →Toujeo LA →fda approvals ↗
    ›May 28, 2025approval458d agoADLYXIN (LIXISENATIDE) — FDA approvalADLYXIN

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

    full page →ADLYXIN →fda approvals ↗
    ›May 28, 2025approval458d agoSAXENDA (LIRAGLUTIDE) — FDA approvalNovo Nordisk Inc

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›May 28, 2025approval458d agoMOUNJARO (TIRZEPATIDE) — FDA approvalZEPBOUND

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

    full page →ZEPBOUND →fda approvals ↗
    ›May 28, 2025approval458d agoSPEVIGO (SPESOLIMAB-SBZO) — FDA approvalspesolimab

    Sponsor: BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Form: INJECTABLE. Route: INTRAVENOUS

    full page →spesolimab →fda approvals ↗
    ›May 28, 2025approval458d agoSPEVIGO (SPESOLIMAB-SBZO) — FDA approvalspesolimab

    Sponsor: BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Form: INJECTABLE. Route: INTRAVENOUS

    full page →spesolimab →fda approvals ↗
    ›May 28, 2025approval458d agoXULTOPHY 100/3.6 (INSULIN DEGLUDEC) — FDA approvalNovo Nordisk Inc

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›May 28, 2025approval458d agoVICTOZA (LIRAGLUTIDE) — FDA approvalSaxenda

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

    full page →Saxenda →fda approvals ↗
    ›May 29, 2025approval457d agoFOCINVEZ (FOSAPREPITANT DIMEGLUMINE) — FDA approvalAthenex Inc (Inactive)

    Sponsor: STERISCIENCE. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›May 29, 2025approval457d agoMETHOTREXATE — FDA approvalMaxtrex

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

    full page →Maxtrex →fda approvals ↗
    ›May 30, 2025approval456d agoACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

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

    full page →ACETAZOLAMIDE →fda approvals ↗

    Week of Jun 2, 2025

    5
    ›Jun 3, 2025approval452d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›Jun 3, 2025approval

    Week of Jun 9, 2025

    13
    ›Jun 9, 2025approval446d agoCOLUMVI (GLOFITAMAB-GXBM) — FDA approvalglofitamab

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

    full page →glofitamab →fda approvals ↗
    ›Jun 10, 2025approval

    Week of Jun 16, 2025

    11
    ›Jun 16, 2025approval439d agoARYNTA (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalLISDEXAMFETAMINE DIMESYLATE

    Sponsor: AZURITY. Form: SOLUTION. Route: ORAL

    full page →LISDEXAMFETAMINE DIMESYLATE →fda approvals ↗
    ›Jun 17, 2025approval

    Week of Jun 23, 2025

    10
    ›Jun 23, 2025approval432d agoAMITRIPTYLINE HYDROCHLORIDE — FDA approvalAlgoTherapeutix SAS

    Sponsor: UNIQUE PHARM. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jun 23, 2025approval
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    452d ago
    ISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

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

    full page →fda approvals ↗
    ›Jun 3, 2025approval452d agoMYORISAN (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

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

    full page →fda approvals ↗
    ›Jun 6, 2025approval449d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›Jun 6, 2025approval449d agoOPUVIZ (AFLIBERCEPT-YSZY) — FDA approvalOPUVIZ

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

    full page →OPUVIZ →fda approvals ↗
    445d ago
    QULIPTA (ATOGEPANT) — FDA approvalatogepant

    Sponsor: ABBVIE. Form: TABLET. Route: ORAL

    full page →atogepant →fda approvals ↗
    ›Jun 10, 2025approval445d agoQULIPTA (ATOGEPANT) — FDA approvalatogepant

    Sponsor: ABBVIE. Form: TABLET. Route: ORAL

    full page →atogepant →fda approvals ↗
    ›Jun 12, 2025approval443d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

    full page →pembrolizumab →fda approvals ↗
    ›Jun 12, 2025approval443d agoVOQUEZNA TRIPLE PAK (AMOXICILLIN) — FDA approvalamoxicillin + clarithromycin + vonoprazan

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

    full page →amoxicillin + clarithromycin + vonoprazan →fda approvals ↗
    ›Jun 12, 2025approval443d agoVOQUEZNA DUAL PAK (AMOXICILLIN) — FDA approvalamoxicillin + vonoprazan fumarate

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

    full page →amoxicillin + vonoprazan fumarate →fda approvals ↗
    ›Jun 12, 2025approval443d agoDELSTRIGO (DORAVIRINE) — FDA approval(doravirine + lamivudine + tenofovir disoproxil fumarate)

    Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL

    full page →(doravirine + lamivudine + tenofovir disoproxil fumarate) →fda approvals ↗
    ›Jun 13, 2025approval442d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Jun 13, 2025approval442d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Jun 13, 2025approval442d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

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

    full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗
    ›Jun 13, 2025approval442d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

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

    full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗
    ›Jun 13, 2025approval442d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

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

    full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗
    ›Jun 13, 2025approval442d agoSTEQEYMA (USTEKINUMAB-STBA) — FDA approvalSTEQEYMA

    Sponsor: CELLTRION, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →STEQEYMA →fda approvals ↗
    438d ago
    XARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    ›Jun 17, 2025approval438d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

    Sponsor: JANSSEN PHARMS. Form: FOR SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Jun 17, 2025approval438d agoMEFENAMIC ACID — FDA approvalMEFENAMIC ACID

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

    full page →MEFENAMIC ACID →fda approvals ↗
    ›Jun 17, 2025approval438d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

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

    full page →guselkumab →fda approvals ↗
    ›Jun 18, 2025approval437d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

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

    full page →dupilumab →fda approvals ↗
    ›Jun 18, 2025approval437d agoZEJULA (NIRAPARIB TOSYLATE) — FDA approvalniraparib

    Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

    full page →niraparib →fda approvals ↗
    ›Jun 18, 2025approval437d agoZEJULA (NIRAPARIB TOSYLATE) — FDA approvalniraparib

    Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

    full page →niraparib →fda approvals ↗
    ›Jun 18, 2025approval437d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

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

    full page →fda approvals ↗
    ›Jun 18, 2025approval437d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

    Sponsor: IMMUNEX. Form: SYRINGE

    full page →fda approvals ↗
    ›Jun 18, 2025approval437d agoAXTLE (PEMETREXED DIPOTASSIUM) — FDA approvalAXTLE

    Sponsor: AVYXA HOLDINGS. Form: POWDER. Route: INTRAVENOUS

    full page →AXTLE →fda approvals ↗
    432d ago
    HADLIMA (ADALIMUMAB-BWWD) — FDA approvalHADLIMA

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

    full page →HADLIMA →fda approvals ↗
    ›Jun 24, 2025approval431d agoTRAZODONE HYDROCHLORIDE — FDA approvalTRAZODONE HYDROCHLORIDE

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

    full page →TRAZODONE HYDROCHLORIDE →fda approvals ↗
    ›Jun 24, 2025approval431d agoTRAZODONE HYDROCHLORIDE — FDA approvalTRAZODONE HYDROCHLORIDE

    Sponsor: APOTEX. Form: TABLET. Route: ORAL

    full page →TRAZODONE HYDROCHLORIDE →fda approvals ↗
    ›Jun 24, 2025approval431d agoMETHADOSE (METHADONE HYDROCHLORIDE) — FDA approvalMETHADONE HYDROCHLORIDE

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

    full page →METHADONE HYDROCHLORIDE →fda approvals ↗
    ›Jun 24, 2025approval431d agoRALDESY (TRAZODONE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: KAMAT. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Jun 25, 2025approval430d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →METHADONE HYDROCHLORIDE →fda approvals ↗
    ›Jun 26, 2025approval429d agoPUR-WASH (PURIFIED WATER) — FDA approval

    Sponsor: NIAGARA PHARMS. Form: SOLUTION. Route: OPHTHALMIC

    full page →fda approvals ↗
    ›Jun 26, 2025approval429d agoCAPRELSA (VANDETANIB) — FDA approvalvandetanib

    Sponsor: GENZYME CORP. Form: TABLET. Route: ORAL

    full page →vandetanib →fda approvals ↗
    ›Jun 27, 2025approval428d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

    Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    $NVO47.19-3.02%
    $LLY1189.41-3.59%
    $REGN813.63-0.14%
    $PHAT8.7700-0.34%
    $MRK153.10-2.14%
    $AMGN439.48-0.20%
    $PHAT8.7700-0.34%
    $JNJ270.00-1.15%
    $ABBV259.04-1.47%
    $ABBV259.04-1.47%