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18,994 catalysts · 18,987 approval · 7,208 phase readout · 5,000 device 510k · 4,728 grant · 3,603 8k filing · 2,000 device pma

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type: pdufa×type: approval×clear all
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  • approval18,987
  • phase readout7,208
  • device 510k5,000
  • grant4,728
  • 8k filing3,603
  • device pma2,000
  • device recall
2,000
  • recall1,126
  • device adverse event1,000
  • earnings585
  • therapy area
    • Dermatology1
    • Infectious Disease1

    Week of Mar 16, 2026

    34
    ›Mar 19, 2026approval164d agoRIFABUTIN — FDA approvali3 Pharmaceuticals LLC

    Sponsor: I3 PHARMS. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Mar 19, 2026approval164d agoSTALEVO 75 (CARBIDOPA) — FDA approvalcarbidopa

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

    full page →carbidopa →fda approvals ↗
    ›Mar 19, 2026approval164d agoVYALEV (FOSCARBIDOPA) — FDA approval(foscarbidopa + foslevodopa)

    Sponsor: ABBVIE. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →(foscarbidopa + foslevodopa) →fda approvals ↗
    ›Mar 19, 2026approval164d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

    Sponsor: NOVO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Mar 19, 2026approval164d agoOPUVIZ (AFLIBERCEPT-YSZY) — FDA approvalOPUVIZ

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

    full page →OPUVIZ →fda approvals ↗
    ›Mar 19, 2026approval164d agoVALGANCICLOVIR HYDROCHLORIDE — FDA approvalVALGANCICLOVIR HYDROCHLORIDE

    Sponsor: MICRO LABS. Form: FOR SOLUTION. Route: ORAL

    full page →VALGANCICLOVIR HYDROCHLORIDE →fda approvals ↗
    ›Mar 19, 2026approval164d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Mar 19, 2026approval164d agoFLAVALTA (EPINEPHRINE BITARTRATE) — FDA approvalDe Motu Cordis Pty Ltd

    Sponsor: DEPROCO. Form: SOLUTION. Route: INJECTION

    full page →fda approvals ↗
    ›Mar 19, 2026approval164d agoDHIVY (CARBIDOPA) — FDA approvalAvion Pharmaceuticals LLC

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

    full page →fda approvals ↗
    ›Mar 19, 2026approval164d agoRYTARY (CARBIDOPA) — FDA approvalOrganon & Co.

    Sponsor: IMPAX. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Mar 19, 2026approval164d agoDEXMETHYLPHENIDATE HYDROCHLORIDE — FDA approvaldexmethylphenidate hydrochloride ER

    Sponsor: AUROLIFE PHARMA LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →dexmethylphenidate hydrochloride ER →fda approvals ↗
    ›Mar 19, 2026approval164d agoDEXMETHYLPHENIDATE HYDROCHLORIDE — FDA approvaldexmethylphenidate hydrochloride ER

    Sponsor: AUROLIFE PHARMA LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →dexmethylphenidate hydrochloride ER →fda approvals ↗
    ›Mar 19, 2026approval164d agoDEXMETHYLPHENIDATE HYDROCHLORIDE — FDA approvaldexmethylphenidate hydrochloride ER

    Sponsor: AUROLIFE PHARMA LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →dexmethylphenidate hydrochloride ER →fda approvals ↗
    ›Mar 19, 2026approval164d agoSINEMET CR (CARBIDOPA) — FDA approvalcarbidopa

    Sponsor: ORGANON LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →carbidopa →fda approvals ↗
    ›Mar 19, 2026approval164d agoCREXONT (CARBIDOPA) — FDA approvalOrganon & Co.

    Sponsor: IMPAX. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Mar 19, 2026approval164d agoIMCIVREE (SETMELANOTIDE ACETATE) — FDA approvalsetmelanotide

    Sponsor: RHYTHM. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →setmelanotide →fda approvals ↗
    ›Mar 19, 2026approval164d agoADRENACLICK (EPINEPHRINE) — FDA approvalViatris Inc

    Sponsor: IMPAX. Form: INJECTABLE. Route: INTRAMUSCULAR, SUBCUTANEOUS

    full page →fda approvals ↗
    ›Mar 19, 2026approval164d agoSINEMET (CARBIDOPA) — FDA approvalcarbidopa

    Sponsor: ORGANON. Form: TABLET. Route: ORAL

    full page →carbidopa →fda approvals ↗
    ›Mar 19, 2026approval164d agoEPHEDRINE SULFATE — FDA approvalEPHEDRINE SULFATE

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

    full page →EPHEDRINE SULFATE →fda approvals ↗
    ›Mar 19, 2026approval164d agoLIDOCAINE HYDROCHLORIDE — FDA approvalInternational Medication Systems Ltd

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

    full page →fda approvals ↗
    ›Mar 20, 2026approval163d agoKETALAR (KETAMINE HYDROCHLORIDE) — FDA approvalPar Pharmaceutical Inc

    Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Mar 20, 2026approval163d agoDEXMEDETOMIDINE HYDROCHLORIDE — FDA approvalDEXMEDETOMIDINE HYDROCHLORIDE

    Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

    full page →DEXMEDETOMIDINE HYDROCHLORIDE →fda approvals ↗
    ›Mar 20, 2026approval163d agoDEXMEDETOMIDINE HYDROCHLORIDE — FDA approvalDEXMEDETOMIDINE HYDROCHLORIDE

    Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

    full page →DEXMEDETOMIDINE HYDROCHLORIDE →fda approvals ↗
    ›Mar 20, 2026approval163d agoXeomin (incobotulinumtoxinA) — FDA approvalMerz Pharmaceuticals LLC

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

    full page →fda approvals ↗
    ›Mar 20, 2026approval163d agoDOXYCYCLINE — FDA approvaldoxycycline ER

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

    full page →doxycycline ER →fda approvals ↗
    ›Mar 20, 2026approval163d agoATONCY (ATOMOXETINE HYDROCHLORIDE) — FDA approvalPrasco LLC

    Sponsor: MAP77. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Mar 20, 2026approval163d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

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

    full page →nivolumab →fda approvals ↗
    ›Mar 20, 2026approval163d agoMEPRON (ATOVAQUONE) — FDA approvalatovaquone

    Sponsor: GLAXOSMITHKLINE LLC. Form: SUSPENSION. Route: ORAL

    full page →atovaquone →fda approvals ↗
    ›Mar 20, 2026approval163d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

    Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Mar 20, 2026approval163d agoTOFACITINIB CITRATE — FDA approvaltofacitinib citrate ER

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

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Mar 20, 2026approval163d agoEPIPEN E Z PEN (EPINEPHRINE) — FDA approvaladrenaline

    Sponsor: VIATRIS. Form: INJECTABLE. Route: INTRAMUSCULAR

    full page →adrenaline →fda approvals ↗
    ›Mar 20, 2026approval163d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

    Sponsor: TORRENT PHARMS. Form: TABLET, CHEWABLE. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Mar 20, 2026approval163d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

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

    full page →carbamazepine ER →fda approvals ↗
    ›Mar 20, 2026approval163d agoLIDOCAINE HYDROCHLORIDE — FDA approvalLaryng-O-Jet

    Sponsor: QUAGEN. Form: SOLUTION. Route: ORAL

    full page →Laryng-O-Jet →fda approvals ↗

    Week of Mar 23, 2026

    16
    ›Mar 23, 2026approval160d agoKETALAR (KETAMINE HYDROCHLORIDE) — FDA approvalPar Pharmaceutical Inc

    Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Mar 23, 2026approval
    ← prev
    page 374 of 380
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    160d ago
    CLINDAMYCIN PHOSPHATE — FDA approvalCLEOCIN

    Sponsor: RISING. Form: SOLUTION. Route: TOPICAL

    full page →CLEOCIN →fda approvals ↗
    ›Mar 23, 2026approval160d agoCEFIXIME — FDA approvalCEFIXIME

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

    full page →CEFIXIME →fda approvals ↗
    ›Mar 23, 2026approval160d agoCINACALCET HYDROCHLORIDE — FDA approvalCINACALCET HYDROCHLORIDE

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

    full page →CINACALCET HYDROCHLORIDE →fda approvals ↗
    ›Mar 23, 2026approval160d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

    full page →tramadol hydrochloride ER →fda approvals ↗
    ›Mar 23, 2026approval160d agoMEXILETINE HYDROCHLORIDE — FDA approvalMEXILETINE HYDROCHLORIDE

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

    full page →MEXILETINE HYDROCHLORIDE →fda approvals ↗
    ›Mar 23, 2026approval160d agoMALARONE PEDIATRIC (ATOVAQUONE) — FDA approvalatovaquone

    Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

    full page →atovaquone →fda approvals ↗
    ›Mar 24, 2026approval159d agoBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE) — FDA approvalAurobindo Pharma Ltd

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

    full page →fda approvals ↗
    ›Mar 24, 2026approval159d agoGUANFACINE HYDROCHLORIDE — FDA approvalGUANFACINE HYDROCHLORIDE

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

    full page →GUANFACINE HYDROCHLORIDE →fda approvals ↗
    ›Mar 24, 2026approval159d agoTICAGRELOR — FDA approvalTICAGRELOR

    Sponsor: ZHEJIANG JINGXIN. Form: TABLET. Route: ORAL

    full page →TICAGRELOR →fda approvals ↗
    ›Mar 24, 2026approval159d agoAVLAYAH (TIVIDENOFUSP ALFA-EKNM) — FDA approvaltividenofusp alfa

    Sponsor: DENALI THERAPEUTICS INC.. Form: INJECTION. Route: POWDER,FOR SOLUTION

    full page →tividenofusp alfa →fda approvals ↗
    ›Mar 24, 2026approval159d agoCHILDREN'S ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) — FDA approvalKenvue Inc.

    Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL

    full page →fda approvals ↗
    ›Mar 24, 2026approval159d agoDYNACIN (MINOCYCLINE HYDROCHLORIDE) — FDA approvalMINOCYCLINE HYDROCHLORIDE

    Sponsor: ALVOGEN. Form: CAPSULE. Route: ORAL

    full page →MINOCYCLINE HYDROCHLORIDE →fda approvals ↗
    ›Mar 24, 2026approval159d agoDYNACIN (MINOCYCLINE HYDROCHLORIDE) — FDA approvalMINOCYCLINE HYDROCHLORIDE

    Sponsor: ALVOGEN. Form: CAPSULE. Route: ORAL

    full page →MINOCYCLINE HYDROCHLORIDE →fda approvals ↗
    ›Mar 24, 2026approval159d agoDYNACIN (MINOCYCLINE HYDROCHLORIDE) — FDA approvalMINOCYCLINE HYDROCHLORIDE

    Sponsor: ALVOGEN. Form: CAPSULE. Route: ORAL

    full page →MINOCYCLINE HYDROCHLORIDE →fda approvals ↗
    ›Mar 24, 2026approval159d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

    full page →fda approvals ↗
    $ABBV255.48-1.03%
    $VTRS16.34-3.26%
    $OGN13.760.00%
    $ORN12.42-2.13%
    $OGN13.760.00%
    $OGN13.760.00%
    $RYTM107.17-4.76%
    $OGN13.760.00%
    $BMY66.58-0.55%
    $VTRS16.34-3.26%
    $DNLI24.67+0.41%
    $KVUE19.20-0.10%