Approvals - Clinical Trials Arena https://www.clinicaltrialsarena.com/sector/approvals/ Hard data and deep insights on clinical trials strategy & operations Fri, 27 Sep 2024 14:07:07 +0000 en-US hourly 1 https://wordpress.org/?v=6.6.2 https://www.clinicaltrialsarena.com/wp-content/uploads/sites/22/2022/01/cropped-Clinical-Trials-Arena-32x32.png Approvals - Clinical Trials Arena https://www.clinicaltrialsarena.com/sector/approvals/ 32 32 BALVERSA for the Treatment of Urothelial Carcinoma, US https://www.clinicaltrialsarena.com/projects/balversa-erdafitinib/ Fri, 27 Sep 2024 14:00:35 +0000 https://www.drugdevelopment-technology.com/?post_type=projects&p=30121 BALVERSA® (erdafitinib) is a fibroblast growth factor receptor (FGFR) kinase inhibitor indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have susceptible FGFR3 genetic alterations and whose disease has progressed following at least one previous lines of systemic treatment.

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]]> FRUZAQLA (fruquintinib) for the Treatment of Metastatic Colorectal Cancer, USA https://www.clinicaltrialsarena.com/projects/fruzaqla-fruquintinib-metastatic-colorectal-cancer/ Thu, 19 Sep 2024 23:57:32 +0000 https://www.clinicaltrialsarena.com/?post_type=projects&p=197693 FRUZAQLA® (fruquintinib) is an oral targeted therapy indicated for adult patients with metastatic colorectal cancer (mCRC).

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]]> Wegovy for the Treatment of Chronic Weight Management, US https://www.clinicaltrialsarena.com/projects/wegovy-semaglutide-weight-management/ Fri, 13 Sep 2024 09:30:01 +0000 https://www.clinicaltrialsarena.com/?post_type=projects&p=139164 Wegovy® (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced diet and increased exercise for chronic weight management in overweight or generally obese adults with at least one weight-related condition such as high blood pressure, Type 2 diabetes (T2D) or high cholesterol.

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]]> Yunovia receives South Korea MFDS approval for Phase I trial of GLP-1 agonist https://www.clinicaltrialsarena.com/news/yunovia-mfds-approval-trial-of-glp-1-agonist/ Wed, 28 Aug 2024 10:54:12 +0000 https://www.clinicaltrialsarena.com/news/yunovia-mfds-approval-trial-of-glp-1-agonist/ Yunovia has announced IND clearance from the MFDS of South Korea for a Phase I study of its glucagon-like peptide-1 agonist, ID110521156.

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]]> ELAHERE for the Treatment of Ovarian Cancer, US https://www.clinicaltrialsarena.com/projects/elahere-for-treatment-of-ovarian-cancer-us/ Thu, 15 Aug 2024 08:40:56 +0000 https://www.clinicaltrialsarena.com/?post_type=projects&p=214176 ELAHERE® (mirvetuximab soravtansine) is a novel antibody-drug conjugate (ADC) indicated for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian cancer and other related malignancies, who have undergone one to three previous systemic therapy courses.

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]]> EC conditionally approves Pfizer’s haemophilia B gene therapy https://www.clinicaltrialsarena.com/news/ec-pfizer-haemophilia-therapy/ Fri, 26 Jul 2024 08:16:18 +0000 https://www.clinicaltrialsarena.com/uncategorized/ec-pfizer-haemophilia-therapy/ The European Commission has awarded conditional marketing authorisation for Pfizer's DURVEQTIX for haemophilia B treatment.

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]]> QALSODY (tofersen) for the Treatment of Amyotrophic Lateral Sclerosis, Europe https://www.clinicaltrialsarena.com/projects/qalsody-tofersen-amyotrophic-lateral-sclerosis-europe/ Tue, 23 Jul 2024 09:37:29 +0000 https://www.clinicaltrialsarena.com/?post_type=projects&p=212304 Biogen's QALSODY (tofersen) is the first targeted therapy approved for a rare, genetic form of amyotrophic lateral sclerosis (ALS), SOD1-ALS.

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]]> Forxiga (dapagliflozin) for Treatment of Type 2 Diabetes https://www.clinicaltrialsarena.com/projects/forxiga-dapagliflozin-for-treatment-of-type-2-diabetes/ https://www.clinicaltrialsarena.com/projects/forxiga-dapagliflozin-for-treatment-of-type-2-diabetes/#respond Fri, 28 Jun 2024 11:30:00 +0000 http://ind-dmp-kgi-verdict-network.pantheonsite.io/drugdevelopment-technology/projects/forxiga-dapagliflozin-for-treatment-of-type-2-diabetes/ Forxiga® (dapagliflozin) is approved for the treatment of paediatric type 2 diabetes, chronic heart failure and chronic kidney disease.

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]]> https://www.clinicaltrialsarena.com/projects/forxiga-dapagliflozin-for-treatment-of-type-2-diabetes/feed/ 0 RYTELO for the Treatment of Myelodysplastic Syndromes, US https://www.clinicaltrialsarena.com/projects/rytelo-treatment-mds/ Fri, 21 Jun 2024 13:56:53 +0000 https://www.clinicaltrialsarena.com/?post_type=projects&p=208365 RYTELO (imetelstat) is indicated for the treatment of low-to-intermediate-1-risk myelodysplastic syndromes (MDS) in adult patients who exhibit transfusion-dependent (TD) anaemia.

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]]> Mounjaro (tirzepatide) for the Treatment of Type 2 Diabetes, USA https://www.clinicaltrialsarena.com/projects/mounjaro-tirzepatide-type-2-diabetes/ Wed, 19 Jun 2024 12:01:18 +0000 https://www.clinicaltrialsarena.com/?post_type=projects&p=157743 Mounjaro (tirzepatide) injection is a new dual-targeted therapy indicated for the management of type 2 diabetes in adults.

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