On December 17, China’s National Medical Products Authority (NMPA) conditionally approved the listing...
Poteligeo for the Treatment of Mycosis Fungoides and Sezary Syndrome
Poteligeo® (mogamulizumab-kpkc) is a monoclonal antibody (mAb) indicated for the treatment of mycosis fungoides and Sézary syndrome in adults.
Vizimpro (dacomitinib) for the Treatment of Non-Small Cell Lung Cancer
Vizimpro® (dacomitinib) is a kinase inhibitor indicated for the treatment of EGFR-positive advanced non-small cell lung cancer (NSCLC) patients diagnosed with exon 19 deletion or exon 21 L858R substitution mutations.
January’s top news stories
Janssen Pharmaceutical Companies of Johnson & Johnson unblinded the Phase III TITAN trial investigating Erleada (apalutamide) in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
Elzonris (tagraxofusp-erzs) for the Treatment of BPDCN
Elzonris™ (tagraxofusp-erzs) is an interleukin-3 receptor alpha chain (CD123) directed cytotoxin that is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and paediatric patients.
Inbrija for the Treatment of OFF Episodes in Parkinson’s Disease
Inbrija™ (levodopa inhalation powder) is an oral formulation indicated for the intermittent treatment of OFF episodes in Parkinson’s disease patients treated with carbidopa/levodopa combination.
DMAb trial for Zika prevention gets FDA approval
The Wistar Institute, Penn Medicine and Inovio Pharmaceuticals have announced the receipt of FDA approval for commencement of a first-in-human clinical trial to probe the safety and tolerability of a new synthetic DNA-encoded monoclonal antibody (DMAb) therapy to prevent Zika virus infection.
Ultomiris (ravulizumab-cwvz) for Paroxysmal Nocturnal Haemoglobinuria
Ultomiris™ (ravulizumab-cwvz) is a complement inhibitor drug approved for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) in adults.
2018: The year’s biggest Drug Development Technology stories
The US National Institutes of Health (NIH) has provided funding for a clinical trial to examine the effectiveness of male contraceptive skin gel NES/T, and GlaxoSmithKline (GSK) has started its Phase III trial evaluating Benlysta (belimumab) in combination with rituximab to treat adult patients with systemic lupus erythematosus (SLE). Drug Development Technology wraps up the key headlines from 2018.
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