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calendar

18,993 catalysts · 18,987 approval · 7,115 phase readout · 5,000 device 510k · 4,728 grant · 3,583 8k filing · 2,000 device pma

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  • approval18,987
  • phase readout7,115
  • device 510k5,000
  • grant4,728
  • 8k filing3,583
  • device pma2,000
  • device recall
2,000
  • recall1,126
  • device adverse event1,000
  • earnings585
  • therapy area
    • Ophthalmology5

    Week of Feb 17, 2025

    8
    ›Feb 21, 2025approval554d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: INDIVIOR. Form: FILM. Route: BUCCAL, SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval554d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

    Sponsor: BARR. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›Feb 21, 2025approval554d agoZUBSOLV (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalEdenbridge Pharmaceuticals LLC

    Sponsor: EDENBRIDGE PHARMS. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›Feb 21, 2025approval554d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval554d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: LANNETT CO INC. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval554d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

    Sponsor: AMNEAL PHARMS. Form: TABLET. Route: SUBLINGUAL

    full page →fda approvals ↗
    ›Feb 21, 2025approval554d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Feb 21, 2025approval554d agoANASTROZOLE — FDA approvalANASTROZOLE

    Sponsor: HIKMA. Form: TABLET. Route: ORAL

    full page →ANASTROZOLE →fda approvals ↗

    Week of Feb 24, 2025

    17
    ›Feb 24, 2025approval551d agoSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 24, 2025approval

    Week of Mar 3, 2025

    23
    ›Mar 3, 2025approval544d agoRIVAROXABAN — FDA approvalJohnson & Johnson Innovative Medicine

    Sponsor: TARO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Mar 3, 2025approval

    Week of Mar 10, 2025

    2
    ›Mar 10, 2025approval537d agoTROKENDI XR (TOPIRAMATE) — FDA approvalSUPERNUS PHARMACEUTICALS, INC.

    Sponsor: SUPERNUS PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Mar 10, 2025approval
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    page 321 of 380
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    551d ago
    POSACONAZOLE — FDA approvalPOSACONAZOLE

    Sponsor: MSN. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →POSACONAZOLE →fda approvals ↗
    ›Feb 24, 2025approval551d agoMIUDELLA (COPPER) — FDA approval

    Sponsor: SEBELA WOMENS HLTH. Form: SYSTEM. Route: INTRAUTERINE

    full page →fda approvals ↗
    ›Feb 25, 2025approval550d agoSTIVARGA (REGORAFENIB) — FDA approvalBayer AG

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

    full page →fda approvals ↗
    ›Feb 26, 2025approval549d agoSONAZINE (CHLORPROMAZINE HYDROCHLORIDE) — FDA approvalSaptalis Pharmaceuticals LLC

    Sponsor: SAPTALIS PHARMS. Form: CONCENTRATE. Route: ORAL

    full page →fda approvals ↗
    ›Feb 26, 2025approval549d agoTEPYLUTE (THIOTEPA) — FDA approvalSTI Pharma LLC

    Sponsor: SHORLA. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Feb 27, 2025approval548d agoPADCEV (ENFORTUMAB VEDOTIN-EJFV) — FDA approvalenfortumab vedotin

    Sponsor: ASTELLAS. Form: INJECTABLE. Route: INJECTION

    full page →enfortumab vedotin →fda approvals ↗
    ›Feb 28, 2025approval547d agoONTRUZANT (TRASTUZUMAB-DTTB) — FDA approvalONTRUZANT

    Sponsor: SAMSUNG BIOEPIS CO LTD. Form: POWDER. Route: IV (INFUSION)

    full page →ONTRUZANT →fda approvals ↗
    ›Feb 28, 2025approval547d agoAK-FLUOR 25% (FLUORESCEIN SODIUM) — FDA approvalLong Grove Pharmaceuticals LLC

    Sponsor: LONG GROVE PHARMS. Form: INJECTABLE. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Feb 28, 2025approval547d agoLYBALVI (OLANZAPINE) — FDA approval(olanzapine + samidorphan l-malate)

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

    full page →(olanzapine + samidorphan l-malate) →fda approvals ↗
    ›Feb 28, 2025approval547d agoZILBRYSQ (ZILUCOPLAN SODIUM) — FDA approvalzilucoplan

    Sponsor: UCB INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →zilucoplan →fda approvals ↗
    ›Feb 28, 2025approval547d agoZILBRYSQ (ZILUCOPLAN SODIUM) — FDA approvalzilucoplan

    Sponsor: UCB INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →zilucoplan →fda approvals ↗
    ›Feb 28, 2025approval547d agoTYENNE (TOCILIZUMAB-AAZG) — FDA approvalTYENNE

    Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS

    full page →TYENNE →fda approvals ↗
    ›Feb 28, 2025approval547d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

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

    full page →fda approvals ↗
    ›Feb 28, 2025approval547d agoOSENVELT (DENOSUMAB-BMWO) — FDA approvalOSENVELT

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

    full page →OSENVELT →fda approvals ↗
    ›Feb 28, 2025approval547d agoEPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (EPINEPHRINE BITARTRATE) — FDA approvalepinephrine bitartrate

    Sponsor: BAXTER HLTHCARE CORP. Form: SOLUTION. Route: INTRAVENOUS

    full page →epinephrine bitartrate →fda approvals ↗
    ›Feb 28, 2025approval547d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

    Sponsor: ALEXION PHARM. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    544d ago
    DASATINIB — FDA approvalXspray Pharma AB

    Sponsor: DR REDDYS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Mar 4, 2025approval543d agoMETHYLENE BLUE — FDA approvalMETHYLENE BLUE

    Sponsor: ZYDUS LIFESCIENCES. Form: SOLUTION. Route: INTRAVENOUS

    full page →METHYLENE BLUE →fda approvals ↗
    ›Mar 5, 2025approval542d agoNEFFY (EPINEPHRINE) — FDA approvalInternational Medication Systems Ltd

    Sponsor: ARS PHARMS OPERATION. Form: SPRAY. Route: NASAL

    full page →fda approvals ↗
    ›Mar 5, 2025approval542d agoELUCIREM (GADOPICLENOL) — FDA approval

    Sponsor: GUERBET. Form: SOLUTION. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Mar 5, 2025approval542d agoGADAVIST (GADOBUTROL) — FDA approval

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

    full page →fda approvals ↗
    ›Mar 5, 2025approval542d agoEOVIST (GADOXETATE DISODIUM) — FDA approval

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

    full page →fda approvals ↗
    ›Mar 5, 2025approval542d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

    Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

    full page →acetaminophen ER →fda approvals ↗
    ›Mar 5, 2025approval542d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

    full page →fda approvals ↗
    ›Mar 5, 2025approval542d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

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

    full page →fda approvals ↗
    ›Mar 6, 2025approval541d agoFUROSCIX (FUROSEMIDE) — FDA approvalFurosemide Sun

    Sponsor: SCPHARMACEUTICALS. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →Furosemide Sun →fda approvals ↗
    ›Mar 6, 2025approval541d agoMINOCYCLINE HYDROCHLORIDE — FDA approvalMINOCYCLINE HYDROCHLORIDE

    Sponsor: TORRENT. Form: CAPSULE. Route: ORAL

    full page →MINOCYCLINE HYDROCHLORIDE →fda approvals ↗
    ›Mar 6, 2025approval541d agoMINOCYCLINE HYDROCHLORIDE — FDA approvalMINOCYCLINE HYDROCHLORIDE

    Sponsor: TORRENT. Form: CAPSULE. Route: ORAL

    full page →MINOCYCLINE HYDROCHLORIDE →fda approvals ↗
    ›Mar 6, 2025approval541d agoMINOCYCLINE HYDROCHLORIDE — FDA approvalMINOCYCLINE HYDROCHLORIDE

    Sponsor: TORRENT. Form: CAPSULE. Route: ORAL

    full page →MINOCYCLINE HYDROCHLORIDE →fda approvals ↗
    ›Mar 7, 2025approval540d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Mar 7, 2025approval540d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

    Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

    full page →dabrafenib mesylate ODT →fda approvals ↗
    ›Mar 7, 2025approval540d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Mar 7, 2025approval540d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

    Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

    full page →dabrafenib mesylate ODT →fda approvals ↗
    ›Mar 7, 2025approval540d agoGLATOPA (GLATIRAMER ACETATE) — FDA approvalGLATIRAMER ACETATE

    Sponsor: SANDOZ. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →GLATIRAMER ACETATE →fda approvals ↗
    ›Mar 7, 2025approval540d agoGLATOPA (GLATIRAMER ACETATE) — FDA approvalGLATIRAMER ACETATE

    Sponsor: SANDOZ. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →GLATIRAMER ACETATE →fda approvals ↗
    ›Mar 7, 2025approval540d agoOMLYCLO (OMALIZUMAB-IGEC) — FDA approvalomalizumab biosimilar

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

    full page →omalizumab biosimilar →fda approvals ↗
    ›Mar 7, 2025approval540d agoSYNJARDY XR (EMPAGLIFLOZIN) — FDA approval(empagliflozin + metformin hydrochloride ER)

    Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →(empagliflozin + metformin hydrochloride ER) →fda approvals ↗
    ›Mar 7, 2025approval540d agoSYNJARDY (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

    Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

    full page →SYNJARDY →fda approvals ↗
    537d ago
    PRIMAQUINE (PRIMAQUINE PHOSPHATE) — FDA approvalprimaquine phosphate

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

    full page →primaquine phosphate →fda approvals ↗
    $INDV35.30-1.47%
    $IGC0.2670+0.41%
    $SUPN44.19-1.54%
    $AMRX17.99+0.39%
    $NVS157.54-1.53%
    $ALKS48.90-0.53%
    $NVS157.54-1.53%
    $NVS157.54-1.53%
    $AZN164.52-1.05%
    $NVS157.54-1.53%