Calendar

pharmadog

Week of Oct 27, 2025

Oct 27, 2025approval306d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: PLIVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 27, 2025approval306d agoOPDIVO QVANTIG (NIVOLUMAB) — FDA approval(hyaluronidase (recombinant, human) + nivolumab)

Sponsor: BRISTOL-MYERS SQUIBB. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →(hyaluronidase (recombinant, human) + nivolumab) →fda approvals ↗

Oct 27, 2025approval306d agoOPDIVO QVANTIG (NIVOLUMAB) — FDA approval(hyaluronidase (recombinant, human) + nivolumab)

Sponsor: BRISTOL-MYERS SQUIBB. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →(hyaluronidase (recombinant, human) + nivolumab) →fda approvals ↗

Oct 27, 2025approval306d agoLOMUSTINE — FDA approvalLOMUSTINE

Sponsor: CARNEGIE. Form: CAPSULE. Route: ORAL

full page →LOMUSTINE →fda approvals ↗

Oct 27, 2025approval306d agoGLYCOPYRROLATE — FDA approvalFresenius Kabi USA LLC

Sponsor: AJENAT PHARMS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Oct 27, 2025approval306d agoCOLUMVI (GLOFITAMAB-GXBM) — FDA approvalglofitamab

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

full page →glofitamab →fda approvals ↗

Oct 27, 2025approval306d agoDUREZOL (DIFLUPREDNATE) — FDA approvalDIFLUPREDNATE

Sponsor: SANDOZ. Form: EMULSION. Route: OPHTHALMIC

full page →DIFLUPREDNATE →fda approvals ↗

Oct 27, 2025approval306d agoPOTASSIUM CHLORIDE — FDA approvalTWi Pharmaceuticals Inc

Sponsor: TWI PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Oct 27, 2025approval306d agoSEVELAMER CARBONATE — FDA approvalRenvela

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

full page →Renvela →fda approvals ↗

Oct 27, 2025approval306d agoASTEPRO ALLERGY (AZELASTINE HYDROCHLORIDE) — FDA approvalWallace Pharmaceuticals Inc

Sponsor: BAYER HLTHCARE. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗

Oct 27, 2025approval306d agoKINERET (ANAKINRA) — FDA approvalSobi Inc

Sponsor: BIOVITRUM AB. Form: VIAL. Route: SUBCUTANEOUS

full page →fda approvals ↗

Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →TICAGRELOR →fda approvals ↗

Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: MSN. Form: TABLET. Route: ORAL

full page →TICAGRELOR →fda approvals ↗

Oct 28, 2025approval305d agoENLON-PLUS (ATROPINE SULFATE) — FDA approvalAccord Healthcare Inc

Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 28, 2025approval305d agoTRIUMEQ (ABACAVIR SULFATE) — FDA approvalViiV Healthcare Company

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

full page →fda approvals ↗

Oct 28, 2025approval305d agoENLON-PLUS (ATROPINE SULFATE) — FDA approvalAccord Healthcare Inc

Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 28, 2025approval305d agoEBGLYSS (LEBRIKIZUMAB-LBKZ) — FDA approvallebrikizumab

Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION

full page →lebrikizumab →fda approvals ↗

Oct 28, 2025approval305d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

full page →fda approvals ↗

Oct 28, 2025approval305d agoDEXTROAMPHETAMINE SULFATE — FDA approvalDEXTROAMPHETAMINE SULFATE

Sponsor: AZURITY. Form: TABLET. Route: ORAL

full page →DEXTROAMPHETAMINE SULFATE →fda approvals ↗

Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

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

full page →fda approvals ↗

Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalSciegen Pharmaceuticals Inc

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

full page →fda approvals ↗

Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

Sponsor: TARO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 28, 2025approval305d agoNICARDIPINE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: QILU PHARM HAINAN. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Oct 28, 2025approval305d agoRENFLEXIS (INFLIXIMAB-ABDA) — FDA approvalinfliximab biosimilar

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

full page →infliximab biosimilar →fda approvals ↗

Oct 28, 2025approval305d agoTIVICAY PD (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

Oct 28, 2025approval305d agoTRIUMEQ PD (ABACAVIR SULFATE) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalTICAGRELOR

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

full page →TICAGRELOR →fda approvals ↗

Oct 28, 2025approval305d agoDROSPIRENONE AND ESTRADIOL (DROSPIRENONE) — FDA approvalExeltis USA Inc

Sponsor: NOVAST LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 28, 2025approval305d agoJULUCA (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

full page →fda approvals ↗

Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

Sponsor: ALKEM LABS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

Sponsor: SUNSHINE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalInvaGen Pharmaceuticals Inc

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

full page →fda approvals ↗

Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

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

full page →fda approvals ↗

Oct 28, 2025approval305d agoDOVATO (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

full page →fda approvals ↗

Oct 28, 2025approval305d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →TICAGRELOR →fda approvals ↗

Oct 29, 2025approval304d agoKETALAR (KETAMINE HYDROCHLORIDE) — FDA approvalPar Pharmaceutical Inc

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

full page →fda approvals ↗

Oct 29, 2025approval304d agoNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (HYDROCORTISONE) — FDA approvalET-800

Sponsor: AMNEAL. Form: SOLUTION/DROPS. Route: OTIC

full page →ET-800 →fda approvals ↗

Oct 29, 2025approval304d agoJUBBONTI (DENOSUMAB-BBDZ) — FDA approvalJUBBONTI

Sponsor: SANDOZ INC. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →JUBBONTI →fda approvals ↗

Oct 29, 2025approval304d agoHIBICLENS (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

Sponsor: MOLNLYCKE HLTH. Form: SOLUTION. Route: TOPICAL

full page →fda approvals ↗

Oct 29, 2025approval304d agoDENOSUMAB-DSSB — FDA approvaldenosumab biosimilar

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

full page →denosumab biosimilar →fda approvals ↗

Oct 29, 2025approval304d agoCONEXXENCE (DENOSUMAB-BNHT) — FDA approvalCONEXXENCE

Sponsor: FRESENIUS KABI USA LLC. Form: INJECTION

full page →CONEXXENCE →fda approvals ↗

Oct 29, 2025approval304d agoOSENVELT (DENOSUMAB-BMWO) — FDA approvalOSENVELT

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

full page →OSENVELT →fda approvals ↗

Oct 29, 2025approval304d agoOSVYRTI (denosumab-desu) — FDA approvalOSVYRTI

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

full page →OSVYRTI →fda approvals ↗

Oct 29, 2025approval304d agoPOSACONAZOLE — FDA approvalPOSACONAZOLE

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

full page →POSACONAZOLE →fda approvals ↗

Oct 29, 2025approval304d agoPIFELTRO (DORAVIRINE) — FDA approvaldoravirine

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

full page →doravirine →fda approvals ↗

Oct 29, 2025approval304d 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 ↗

Oct 29, 2025approval304d agoAUKELSO (DENOSUMAB-KYQQ) — FDA approvalAUKELSO

Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION

full page →AUKELSO →fda approvals ↗

Oct 29, 2025approval304d agoENOBY (DENOSUMAB-QBDE) — FDA approvalENOBY

Sponsor: HIKMA PHARMACEUTICALS USA INC. Form: SOLUTION. Route: INJECTION

full page →ENOBY →fda approvals ↗

Oct 29, 2025approval304d agoBILPREVDA (DENOSUMAB-NXXP) — FDA approvalBILPREVDA

Sponsor: SHANGHAI HENLIUS BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →BILPREVDA →fda approvals ↗

Oct 29, 2025approval304d agoVARENICLINE TARTRATE — FDA approvalVARENICLINE TARTRATE

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

full page →VARENICLINE TARTRATE →fda approvals ↗

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Week of Oct 27, 2025