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Vabysmo (faricimab) showed extended durability, continued efficacy and a consistent safety profile in long-term diabetic macular edema study – Roche

Written by | 20 Jul 2024

Roche announced four-year data from the RHONE-X extension study. The study met all primary endpoints, showing that Vabysmo (faricimab) was well tolerated in people with diabetic macular edema… read more.

MHRA (UK) has approved the subcutaneous version of Ocrevus to treat patients with relapsing and primary progressive multiple sclerosis – Roche

Written by | 19 Jul 2024

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Roche’s subcutaneous version of Ocrevus (ocrelizumab subcutaneous ) to treat patients with relapsing and primary progressive… read more.

Darolutamide meets primary endpoint in phase III ARANOTE trial in men with metastatic hormone-sensitive prostate cancer – Bayer + Orion

Written by | 18 Jul 2024

The Phase III ARANOTE trial, investigating darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC), has met its primary endpoint of rPFS.( radiological progression-free survival). Darolutamide… read more.

UK MHRA grants marketing authorization for Lytenava (bevacizumab gamma) for the treatment of wet AMD – Outlook Therapeutics

Written by | 17 Jul 2024

Outlook Therapeutics, Inc. announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Lytenava (bevacizumab gamma), an ophthalmic formulation of… read more.

FDA issues Complete Response Letter for once weekly basal insulin icodec – Novo Nordisk

Written by | 16 Jul 2024

Novo Nordisk announced that the FDA has issued a Complete Response Letter covering the Biologics License Application for once-weekly basal insulin icodec for the treatment of diabetes mellitus…. read more.

Jeraygo (aprocitentan) approved in Europe as first and only ERA for the treatment of resistant hypertension – Idorsia Ltd

Written by | 15 Jul 2024

Idorsia Ltd announced that the European Commission (EC) has approved Jeraygo (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive… read more.

Dupixent (dupilumab) approved in the EU as the first-ever targeted therapy for patients with COPD – Sanofi + Regeneron

Written by | 14 Jul 2024

The European Medicines Agency (EMA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils…. read more.

FDA approves Zoryve (roflumilast) cream 0.15% for the treatment of atopic dermatitis in adults and children down to 6 years of age – Arcutis Biotherapeutics

Written by | 13 Jul 2024

Arcutis Biotherapeutics, Inc. announced the FDA has approved the supplemental new drug application (sNDA) for Zoryve (roflumilast) cream, 0.15%, for the treatment of mild to moderate atopic dermatitis… read more.

Risk of nonarteritic anterior ischemic optic neuropathy (NAION) in patients prescribed semaglutide – Novo Nordisk

Written by | 12 Jul 2024

A new observational study reported for the first time a potential link between Novo Nordisk’s GLP-1 drugs Ozempic and Wegovy and an eye condition that can cause vision… read more.

CE Mark for Accu-Chek SmartGuide, an AI-enabled continuous glucose monitoring solution , offering critical predictions to people living with diabetes – Roche

Written by | 11 Jul 2024

Roche announced that it has received the CE Mark for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution. This significant milestone paves the way for the solution to… read more.

Kevzara (sarilumab) approved by FDA for the treatment of active polyarticular juvenile idiopathic arthritis – Regeneron + Sanofi

Written by | 10 Jul 2024

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has approved Kevzara (sarilumab) for the treatment of patients weighing 63 kg or greater with active polyarticular juvenile idiopathic… read more.

Biocon Biologics obtains FDA approval for biosimilar aflibercept for Yesafili and enters U.S. ophthalmology market

Written by | 9 Jul 2024

Biocon Biologics Ltd (BBL),announced that the FDA has approved the Company’s first-to-file application for Yesafili (aflibercept-jbvf), an interchangeable biosimilar aflibercept. Yesafili, a vascular endothelial growth factor (VEGF) inhibitor… read more.

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