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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: approval×type: pdufa×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 Jan 19, 2026

    30
    ›Jan 22, 2026approval220d agoZILBRYSQ (ZILUCOPLAN SODIUM) — FDA approvalzilucoplan

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

    full page →zilucoplan →fda approvals ↗
    ›Jan 22, 2026approval220d agoROPINIROLE HYDROCHLORIDE — FDA approvalElite Laboratories Inc

    Sponsor: CHARTWELL RX. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 22, 2026approval220d agoROPINIROLE HYDROCHLORIDE — FDA approvalElite Laboratories Inc

    Sponsor: CHARTWELL RX. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 22, 2026approval220d agoESTRADIOL — FDA approvalestradiol ER

    Sponsor: EPIC PHARMA LLC. Form: TABLET. Route: ORAL

    full page →estradiol ER →fda approvals ↗
    ›Jan 23, 2026approval219d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

    Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

    full page →fda approvals ↗
    ›Jan 23, 2026approval219d agoEPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

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

    full page →EPYSQLI →fda approvals ↗
    ›Jan 23, 2026approval219d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

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

    full page →fda approvals ↗
    ›Jan 23, 2026approval219d agoOLANZAPINE — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

    Sponsor: OMNIVIUM PHARMS. Form: POWDER. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›Jan 23, 2026approval219d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalnaloxone hydrochloride

    Sponsor: LUPIN. Form: TABLET. Route: ORAL

    full page →naloxone hydrochloride →fda approvals ↗
    ›Jan 23, 2026approval219d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalnaloxone hydrochloride

    Sponsor: LUPIN. Form: TABLET. Route: ORAL

    full page →naloxone hydrochloride →fda approvals ↗
    ›Jan 23, 2026approval219d agoAFREZZA (INSULIN RECOMBINANT HUMAN) — FDA approvalinsulin human

    Sponsor: MANNKIND. Form: POWDER. Route: INHALATION

    full page →insulin human →fda approvals ↗
    ›Jan 23, 2026approval219d agoJOURNAVX (SUZETRIGINE) — FDA approvalsuzetrigine

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

    full page →suzetrigine →fda approvals ↗
    ›Jan 24, 2026approval218d agoDILTIAZEM HYDROCHLORIDE — FDA approvalBausch Health US LLC

    Sponsor: PH HEALTH. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 24, 2026approval218d agoDILTIAZEM HYDROCHLORIDE — FDA approvalBausch Health US LLC

    Sponsor: PH HEALTH. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 24, 2026approval218d agoCARTIA XT (DILTIAZEM HYDROCHLORIDE) — FDA approvalBausch Health US LLC

    Sponsor: ACTAVIS LABS FL INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 24, 2026approval218d agoCARTIA XT (DILTIAZEM HYDROCHLORIDE) — FDA approvalBausch Health US LLC

    Sponsor: ACTAVIS LABS FL INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 24, 2026approval218d agoCARTIA XT (DILTIAZEM HYDROCHLORIDE) — FDA approvalBausch Health US LLC

    Sponsor: ACTAVIS LABS FL INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 24, 2026approval218d agoNAPROXEN SODIUM — FDA approvalBayer HealthCare Pharmaceuticals Inc

    Sponsor: TEVA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jan 24, 2026approval218d agoNAPROXEN SODIUM — FDA approvalBayer HealthCare Pharmaceuticals Inc

    Sponsor: TEVA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jan 24, 2026approval218d agoNAPROXEN SODIUM — FDA approvalBayer HealthCare Pharmaceuticals Inc

    Sponsor: TEVA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jan 24, 2026approval218d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

    Sponsor: RISING. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

    full page →divalproex sodium DR →fda approvals ↗
    ›Jan 24, 2026approval218d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

    Sponsor: RISING. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

    full page →divalproex sodium DR →fda approvals ↗
    ›Jan 24, 2026approval218d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

    Sponsor: RISING. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

    full page →divalproex sodium DR →fda approvals ↗
    ›Jan 25, 2026approval217d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Jan 25, 2026approval217d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Jan 25, 2026approval217d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Jan 25, 2026approval217d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Jan 25, 2026approval217d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Jan 25, 2026approval217d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Jan 25, 2026approval217d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

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

    full page →fda approvals ↗

    Week of Jan 26, 2026

    20
    ›Jan 26, 2026approval216d agoAMLODIPINE BESYLATE — FDA approvalGraviti Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Jan 26, 2026approval
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    page 361 of 380
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    216d ago
    BETAMETHASONE DIPROPIONATE — FDA approvalBETAMETHASONE DIPROPIONATE

    Sponsor: AUROBINDO PHARMA LTD. Form: CREAM. Route: TOPICAL

    full page →BETAMETHASONE DIPROPIONATE →fda approvals ↗
    ›Jan 26, 2026approval216d agoPALIPERIDONE — FDA approvalpaliperidone ER

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

    full page →paliperidone ER →fda approvals ↗
    ›Jan 26, 2026approval216d agoMETHYLPREDNISOLONE ACETATE — FDA approvalPFIZER INC

    Sponsor: CAPLIN. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Jan 26, 2026approval216d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

    Sponsor: AMNEAL. Form: TABLET. Route: ORAL

    full page →DOXYCYCLINE HYCLATE →fda approvals ↗
    ›Jan 26, 2026approval216d agoFINASTERIDE — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: TEVA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jan 26, 2026approval216d agoCHLORPROMAZINE HYDROCHLORIDE — FDA approvalCHLORPROMAZINE HYDROCHLORIDE

    Sponsor: MSN. Form: INJECTABLE. Route: INJECTION

    full page →CHLORPROMAZINE HYDROCHLORIDE →fda approvals ↗
    ›Jan 26, 2026approval216d agoTRANEXAMIC ACID — FDA approvalHyloris Pharmaceuticals SA

    Sponsor: I 3 PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jan 26, 2026approval216d agoDIFLUPREDNATE — FDA approvalDIFLUPREDNATE

    Sponsor: ALEMBIC. Form: EMULSION. Route: OPHTHALMIC

    full page →DIFLUPREDNATE →fda approvals ↗
    ›Jan 26, 2026approval216d agoTAPENTADOL HYDROCHLORIDE — FDA approvaltapentadol hydrochloride ER

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

    full page →tapentadol hydrochloride ER →fda approvals ↗
    ›Jan 26, 2026approval216d agoDAPTOMYCIN — FDA approvalDaptomycin Novo

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

    full page →Daptomycin Novo →fda approvals ↗
    ›Jan 26, 2026approval216d agoBUDESONIDE — FDA approvalbudesonide DR

    Sponsor: RISING. Form: CAPSULE, DELAYED RELEASE. Route: ORAL

    full page →budesonide DR →fda approvals ↗
    ›Jan 26, 2026approval216d agoQUIOFIC (FOLIC ACID) — FDA approvalfolic acid

    Sponsor: SOLUBIOMIX. Form: SOLUTION. Route: ORAL

    full page →folic acid →fda approvals ↗
    ›Jan 26, 2026approval216d agoCUPRIC CHLORIDE — FDA approvalCUPRIC CHLORIDE

    Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION

    full page →CUPRIC CHLORIDE →fda approvals ↗
    ›Jan 27, 2026approval215d agoDARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ) — FDA approval(daratumumab + hyaluronidase (human recombinant))

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

    full page →(daratumumab + hyaluronidase (human recombinant)) →fda approvals ↗
    ›Jan 27, 2026approval215d agoNOXAFIL POWDERMIX KIT (POSACONAZOLE) — FDA approvalPOSACONAZOLE

    Sponsor: MSD MERCK CO. Form: FOR SUSPENSION, DELAYED RELEASE. Route: ORAL

    full page →POSACONAZOLE →fda approvals ↗
    ›Jan 27, 2026approval215d agoTAPENTADOL HYDROCHLORIDE — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

    Sponsor: HUMANWELL. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Jan 27, 2026approval215d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

    full page →POSACONAZOLE →fda approvals ↗
    ›Jan 27, 2026approval215d agoFIDAXOMICIN — FDA approvalDificid

    Sponsor: TORRENT. Form: TABLET. Route: ORAL

    full page →Dificid →fda approvals ↗
    ›Jan 27, 2026approval215d agoVYXEOS (CYTARABINE) — FDA approvalMeitheal Pharmaceuticals Inc

    Sponsor: JAZZ PHARMS THERAP. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    $CPIX8.4600-2.20%
    $TEVA36.44-3.14%
    $MNKD4.0600-0.73%
    $VERX14.30+5.46%
    $PFE27.96-0.21%
    $AMRX17.54-2.61%
    $AMRX17.54-2.61%
    $COLL26.44-3.89%
    $MRK148.35-0.80%