Calendar

pharmadog

Week of Nov 17, 2025

Nov 17, 2025approval285d agoONDANSETRON — FDA approvalondansetron ODT

Sponsor: SANDOZ. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →ondansetron ODT →fda approvals ↗

Nov 17, 2025approval285d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

full page →atezolizumab →fda approvals ↗

Nov 17, 2025approval285d agoPANRETIN (ALITRETINOIN) — FDA approvalalitretinoin

Sponsor: ADVANZ PHARMA. Form: GEL. Route: TOPICAL

full page →alitretinoin →fda approvals ↗

Nov 17, 2025approval285d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: GLAND PHARMA LTD. Form: INJECTABLE. Route: INJECTION

full page →ondansetron hydrochloride CR →fda approvals ↗

Nov 17, 2025approval285d agoNATACYN (NATAMYCIN) — FDA approvalHARROW, INC.

Sponsor: HARROW EYE. Form: SUSPENSION. Route: OPHTHALMIC

full page →fda approvals ↗

Nov 18, 2025approval284d agoEPKINLY (EPCORITAMAB-BYSP) — FDA approvalepcoritamab

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

full page →epcoritamab →fda approvals ↗

Nov 18, 2025approval284d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

Sponsor: RISING. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

Nov 18, 2025approval284d agoDICHLORPHENAMIDE — FDA approvalDICHLORPHENAMIDE

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →DICHLORPHENAMIDE →fda approvals ↗

Nov 18, 2025approval284d agoTAMSULOSIN HYDROCHLORIDE — FDA approvalTAMSULOSIN HYDROCHLORIDE

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

full page →TAMSULOSIN HYDROCHLORIDE →fda approvals ↗

Nov 18, 2025approval284d agoFLUPHENAZINE HYDROCHLORIDE — FDA approvalFLUPHENAZINE HYDROCHLORIDE

Sponsor: HETERO LABS LTD III. Form: TABLET. Route: ORAL

full page →FLUPHENAZINE HYDROCHLORIDE →fda approvals ↗

Nov 18, 2025approval284d agoNIZORAL ANTI-DANDRUFF (KETOCONAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: KRAMER. Form: SHAMPOO. Route: TOPICAL

full page →fda approvals ↗

Nov 18, 2025approval284d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

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

full page →PYZCHIVA →fda approvals ↗

Nov 18, 2025approval284d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

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

full page →PYZCHIVA →fda approvals ↗

Nov 18, 2025approval284d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →ondansetron hydrochloride CR →fda approvals ↗

Nov 18, 2025approval284d agoSUPREP BOWEL PREP KIT (MAGNESIUM SULFATE) — FDA approvalMAGNESIUM SULFATE

Sponsor: AZURITY. Form: SOLUTION. Route: ORAL

full page →MAGNESIUM SULFATE →fda approvals ↗

Nov 18, 2025approval284d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalondansetron hydrochloride CR

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →ondansetron hydrochloride CR →fda approvals ↗

Nov 18, 2025approval284d agoREDEMPLO (PLOZASIRAN SODIUM) — FDA approvalplozasiran sodium

Sponsor: ARROWHEAD. Form: SOLUTION. Route: SUBCUTANEOUS

full page →plozasiran sodium →fda approvals ↗

Nov 19, 2025approval283d agoEYLEA HD (AFLIBERCEPT) — FDA approvalEYLEA HD

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

full page →EYLEA HD →fda approvals ↗

Nov 19, 2025approval283d 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 ↗

Nov 19, 2025approval283d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Nov 19, 2025approval283d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Nov 19, 2025approval283d agoNILOTINIB HYDROCHLORIDE — FDA approvalNILOTINIB HYDROCHLORIDE

Sponsor: HETERO LABS LTD V. Form: CAPSULE. Route: ORAL

full page →NILOTINIB HYDROCHLORIDE →fda approvals ↗

Nov 19, 2025approval283d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

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

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Nov 19, 2025approval283d agoIMDELLTRA (TARLATAMAB-DLLE) — FDA approvaltarlatamab

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

full page →tarlatamab →fda approvals ↗

Nov 19, 2025approval283d agoNILOTINIB HYDROCHLORIDE — FDA approvalHetero Labs Ltd

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

full page →fda approvals ↗

Nov 19, 2025approval283d agoHEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HEPARIN SODIUM) — FDA approvalHEPARIN SODIUM

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →HEPARIN SODIUM →fda approvals ↗

Nov 19, 2025approval283d agoIGALMI (DEXMEDETOMIDINE HYDROCHLORIDE) — FDA approvaldexmedetomidine

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

full page →dexmedetomidine →fda approvals ↗

Nov 19, 2025approval283d agoNILOTINIB HYDROCHLORIDE — FDA approvalNILOTINIB HYDROCHLORIDE

Sponsor: MSN. Form: CAPSULE. Route: ORAL

full page →NILOTINIB HYDROCHLORIDE →fda approvals ↗

Nov 19, 2025approval283d agoKOSELUGO (SELUMETINIB SULFATE) — FDA approvalselumetinib sulfate

Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL

full page →selumetinib sulfate →fda approvals ↗

Nov 19, 2025approval283d agoKOSELUGO (SELUMETINIB) — FDA approvalselumetinib sulfate

Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL

full page →selumetinib sulfate →fda approvals ↗

Nov 19, 2025approval283d agoHYRNUO (SEVABERTINIB) — FDA approvalsevabertinib

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

full page →sevabertinib →fda approvals ↗

Nov 19, 2025approval283d agoROPINIROLE HYDROCHLORIDE — FDA approvalropinirole hydrochloride ER

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

full page →ropinirole hydrochloride ER →fda approvals ↗

Nov 20, 2025approval282d agoPALYNZIQ (PEGVALIASE-PQPZ) — FDA approvalBIOMARIN PHARMACEUTICAL INC

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

full page →fda approvals ↗

Nov 20, 2025approval282d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Nov 20, 2025approval282d agoPOTASSIUM CHLORIDE — FDA approvalPOTASSIUM CHLORIDE

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

full page →POTASSIUM CHLORIDE →fda approvals ↗

Nov 20, 2025approval282d agoIMULDOSA (USTEKINUMAB-SRLF) — FDA approvalustekinumab biosimilar

Sponsor: ACCORD BIOPHARMA INC.. Form: INJECTABLE. Route: INTRAVENOUS

full page →ustekinumab biosimilar →fda approvals ↗

Nov 20, 2025approval282d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

full page →selpercatinib →fda approvals ↗

Nov 20, 2025approval282d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

full page →selpercatinib →fda approvals ↗

Nov 20, 2025approval282d agoSERTRALINE HYDROCHLORIDE — FDA approvalSERTRALINE HYDROCHLORIDE

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

full page →SERTRALINE HYDROCHLORIDE →fda approvals ↗

Nov 20, 2025approval282d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

full page →selpercatinib →fda approvals ↗

Nov 20, 2025approval282d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

full page →selpercatinib →fda approvals ↗

Nov 20, 2025approval282d agoCLOBETASOL PROPIONATE — FDA approvalClobetasol Propionate Teva

Sponsor: XIROMED. Form: AEROSOL, FOAM. Route: TOPICAL

full page →Clobetasol Propionate Teva →fda approvals ↗

Nov 21, 2025approval281d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

Nov 21, 2025approval281d agoKEYTRUDA QLEX (PEMBROLIZUMAB) — FDA approval(berahyaluronidase alfa + pembrolizumab)

Sponsor: MERCK SHARP DOHME. Form: INJECTABLE. Route: INJECTION

full page →(berahyaluronidase alfa + pembrolizumab) →fda approvals ↗

Nov 21, 2025approval281d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Nov 21, 2025approval281d agoNARCAN (NALOXONE HYDROCHLORIDE) — FDA approvalEmergent Devices Inc

Sponsor: EMERGENT. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗

Nov 21, 2025approval281d agoNEXLETOL (BEMPEDOIC ACID) — FDA approvalbempedoic acid

Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

full page →bempedoic acid →fda approvals ↗

Nov 21, 2025approval281d agoNEXLIZET (BEMPEDOIC ACID) — FDA approval(bempedoic acid + ezetimibe)

Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

full page →(bempedoic acid + ezetimibe) →fda approvals ↗

Nov 21, 2025approval281d agoLIVTENCITY (MARIBAVIR) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Nov 21, 2025approval281d agoURSODIOL — FDA approvalURSODIOL

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

full page →URSODIOL →fda approvals ↗

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Week of Nov 17, 2025