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Results For "pharmacokinetic"

83 News Found

Aptar commences clinical study to accelerate FDA approval of SmartTrack
News | April 19, 2025

Aptar commences clinical study to accelerate FDA approval of SmartTrack

SmartTrack aims to reduce the need for clinical studies in generic drug product approvals


Biocon Biologics announces USFDA approval for Jobevne biosimilar Bevacizumab
Drug Approval | April 11, 2025

Biocon Biologics announces USFDA approval for Jobevne biosimilar Bevacizumab

Jobevne is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis


Merck seeks FDA approval for subcutaneous pembrolizumab
Drug Approval | March 29, 2025

Merck seeks FDA approval for subcutaneous pembrolizumab

Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy


Biocon Biologics announces positive results from Phase 3 study of Yesintek biosimilar to Ustekinumab for chronic plaque psoriasis
Diagnostic Center | March 08, 2025

Biocon Biologics announces positive results from Phase 3 study of Yesintek biosimilar to Ustekinumab for chronic plaque psoriasis

The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara


Biocon Biologics launches Yesintek Biosimilar to Stelara in US
News | February 25, 2025

Biocon Biologics launches Yesintek Biosimilar to Stelara in US

YESINTEK is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis


Teva and Sanofi present new outcome from Phase 2b study of duvakitug
News | February 25, 2025

Teva and Sanofi present new outcome from Phase 2b study of duvakitug

Findings to form the basis for a Phase 3 program, anticipated to start in H2 2025


Innocan Pharma granted first patent in India for its Liposomal CBD Injection
News | February 20, 2025

Innocan Pharma granted first patent in India for its Liposomal CBD Injection

Innovative chronic pain treatment receives IP protection in India's $55 billion pharmaceutical market


CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA
News | February 03, 2025

CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA

Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia


Zydus Lifesciences receives approval from USFDA to conduct Phase II(b) clinical trial for Usnoflas
Drug Approval | January 19, 2025

Zydus Lifesciences receives approval from USFDA to conduct Phase II(b) clinical trial for Usnoflas

This study will enrol 210 ALS patients and study doses of 50 mg and 75 mg Usnoflast versus placebo


Iconovo and Lonza to collaborate on formulation development of an intranasal biologic
News | January 13, 2025

Iconovo and Lonza to collaborate on formulation development of an intranasal biologic

Lonza to develop spray-dried formulations for an intranasally-delivered biologic for Iconovo at its Center of Excellence for bioavailability enhancement and inhaled delivery in Bend (US)