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ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of HER2-positive...
ENHERTU is the first antibody-drug conjugate available for adults to treat locally advanced or metastatic HER2-positive gastric cancer.The post ENHERTU (fam-trastuzumab deruxtecan-nxki) for the...
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XOLREMDI (mavorixafor) for the Treatment of WHIM Syndrome, US
XOLREMDI (mavorixafor), a CXCR4 antagonist, is the first approved therapy indicated to treat patients with WHIM syndrome.The post XOLREMDI (mavorixafor) for the Treatment of WHIM Syndrome, US appeared...
View ArticleELAHERE for the Treatment of Ovarian Cancer, US
ELAHERE® is a novel ADC indicated for the treatment of adult patients with FRα-positive, platinum-resistant epithelial ovarian cancer. The post ELAHERE for the Treatment of Ovarian Cancer, US appeared...
View ArticleTezspire (tezepelumab-ekko) for the Treatment of Severe Asthma, US
Tezspire (tezepelumab-ekko) is a first-in-class human monoclonal antibody indicated for add-on maintenance treatment of severe asthma. The post Tezspire (tezepelumab-ekko) for the Treatment of Severe...
View ArticleGEMTESA for the Treatment of Overactive Bladder, US
GEMTESA (vibegron) is an oral medication indicated for the treatment of OAB with signs of UUI, urgency and urinary frequency in adults. The post GEMTESA for the Treatment of Overactive Bladder, US...
View ArticleFilspari (sparsentan) for the Reduction of Proteinuria in IgA Nephropathy, US
Filspari (sparsentan) is a first-of-its-kind, oral non-immunosuppressive therapy indicated for reducing proteinuria in IgA nephropathy. The post Filspari (sparsentan) for the Reduction of Proteinuria...
View ArticleSunlenca (Lenacapavir) for the Treatment of HIV-1 Infection, US
Sunlenca (lenacapavir) is a first-in-class, long-acting HIV capsid inhibitor approved for the treatment of HIV-1 infection. The post Sunlenca (Lenacapavir) for the Treatment of HIV-1 Infection, US...
View ArticleCinnaGen Enters EU Market with EMA Approval for Zandoriah®
The post CinnaGen Enters EU Market with EMA Approval for Zandoriah® appeared first on Clinical Trials Arena.
View ArticleModeyso (dordaviprone) for the Treatment of Diffuse Midline Glioma, US
Modeyso™ (dordaviprone) is indicated for the treatment of adult and paediatric patients aged one year and older with diffuse midline glioma. The post Modeyso (dordaviprone) for the Treatment of Diffuse...
View ArticleJascayd (nerandomilast) for the Treatment of Idiopathic Pulmonary Fibrosis...
Jascayd® is a PDE4 inhibitor indicated to treat adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). The post Jascayd (nerandomilast) for the Treatment of...
View ArticleBriumvi (ublituximab-xiiy) for the Treatment of Multiple Sclerosis, US
Briumvi (ublituximab-xiiy) is the first anti-CD20 monoclonal antibody for the treatment of adults with relapsing forms of multiple sclerosis. The post Briumvi (ublituximab-xiiy) for the Treatment of...
View ArticleBreyanzi for the Treatment of Large B-cell Lymphoma, US
Breyanzi (lisocabtagene maraleucel) is a CD19-directed chimeric antigen receptor (CAR) T-cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory (r/r) large B-cell...
View ArticleENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of HER2 positive...
ENHERTU is the first antibody-drug conjugate available for adults to treat locally advanced or metastatic HER2-positive gastric cancer. The post ENHERTU (fam-trastuzumab deruxtecan-nxki) for the...
View ArticleCHMP recommends GSK’s Blenrep approval for multiple myeloma treatment
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of GSK’s Blenrep. The post CHMP recommends GSK’s Blenrep approval for multiple...
View ArticleEC grants orphan drug designation to Dyne Therapeutics’ DMD therapy
The EC has granted orphan drug designation to Dyne Therapeutics’ DYNE-251 for treating Duchenne muscular dystrophy (DMD). The post EC grants orphan drug designation to Dyne Therapeutics’ DMD therapy...
View ArticleDaiichi and AstraZeneca’s Enhertu gains EC approval for breast cancers
The EC has approved Daiichi Sankyo and AstraZeneca’s Enhertu for use as a single agent to treat adults with certain breast cancers. The post Daiichi and AstraZeneca’s Enhertu gains EC approval for...
View ArticleGenmab’s Tivdak approved in Japan for advanced cervical cancer
Genmab has received approval from Japan's Ministry of Health, Labour and Welfare for its Tivdak to treat cervical cancer. The post Genmab’s Tivdak approved in Japan for advanced cervical cancer...
View ArticleFDA approves GSK’s Blujepa for uncomplicated UTIs
The FDA has approved GSK’s Blujepa for treating uncomplicated urinary tract infections (uUTIs) in adult females and paediatric patients. The post FDA approves GSK’s Blujepa for uncomplicated UTIs...
View ArticleEC approves Bristol Myers Squibb’s follicular lymphoma CAR T therapy
The EC has granted expanded approval to BMS' Breyanzi, to treat adults with relapsed or refractory follicular lymphoma (FL). The post EC approves Bristol Myers Squibb’s follicular lymphoma CAR T...
View ArticleFDA grants ODD status to Zai Lab’s lung cancer treatment
The FDA has granted orphan drug designation (ODD) to Zai Lab’s ZL-1310, aimed at treating small cell lung cancer (SCLC). The post FDA grants ODD status to Zai Lab’s lung cancer treatment appeared first...
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