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Wegovy approved in the US for cardiovascular risk reduction in people with overweight or obesity and established cardiovascular disease – Novo Nordisk

Written by | 14 Mar 2024

Novo Nordisk announced that the FDA has approved a label expansion for Wegovy based on a supplemental New Drug Application (sNDA) for the indication of reducing risks of… read more.

Dupixent provides late-breaking results showing reduced airway inflammation and mucus plugging in adults with uncontrolled moderate-to-severe asthma – Sanofi + Regeneron

Written by | 13 Mar 2024

Topline results from the VESTIGE Phase IV clinical trial evaluating the effect of Dupixent (dupilumab) on airway remodeling parameters through the use of functional respiratory imaging (FRI) in… read more.

New research reveals genomic profile of seborrheic dermatitis and answers key questions on immune response and skin barrier dysfunction – Arcutis Biotherapeutics Inc

Written by | 12 Mar 2024

Arcutis Biotherapeutics, Inc., highlights new research that, for the first time, reveals the gene expression profile of seborrheic dermatitis . The Arcutis sponsored research from The Kimberly and… read more.

New data is presented at MDA meeting of Zolgensma (onasemnogene abeparvovec) from the SMART study for the treatment of spinal muscular atrophy – Novartis

Written by | 11 Mar 2024

Novartis presented new data that continue to support the clinical benefits of Zolgensma (onasemnogene abeparvovec), the only one-time gene therapy for the treatment of spinal muscular atrophy (SMA)…. read more.

FDA approves APP 13007 (clobetasol propionate ophthalmic suspension 0.05%) for post operative inflammation and pain following ocular surgery – Eyenovia

Written by | 10 Mar 2024

The FDA has approved clobetasol propionate ophthalmic suspension 0.05% (APP 13007) by Taiwan-based Formosa Pharmaceuticals and AimMax Therapeutics. This suspension for the treatment of post-operative inflammation and pain… read more.

FDA approval for first and only denosumab biosimilars – Sandoz

Written by | 9 Mar 2024

Sandoz, announced that the FDA approved Wyost (denosuab-bbdz) and Jubbonti (denosumab-bbdz), the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines Keren Haruvi,… read more.

FDA approval for the Agent drug-coated balloon to treat coronary in-stent restenosis in patients with coronary artery disease – Boston Scientific

Written by | 8 Mar 2024

Boston Scientific Corporation announced it has received FDA approval for the Agent Drug-Coated Balloon (DCB), which is indicated to treat coronary in-stent restenosis (ISR) in patients with coronary… read more.

CE Mark for Varipulse Platform for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation – Biosense Webster (J&J)

Written by | 7 Mar 2024

Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, announced European CE mark approval of the Varipulse Platform for the… read more.

European Medicines Agency validation for MAA of nirogacestat for the treatment of adults with desmoid tumors – Springworks Therapeutics

Written by | 6 Mar 2024

SpringWorks Therapeutics, Inc. announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for nirogacestat, an oral gamma secretase inhibitor, for the treatment of… read more.

Hepatology publishes six-year data demonstrating improved clinical outcomes in patients with Alagille syndrome treated with Livmarli (maralixibat) – Mirum Pharma

Written by | 5 Mar 2024

Mirum Pharmaceuticals, Inc. announced that Hepatology published an analysis demonstrating a statistically significant improvement in six-year event-free and transplant-free survival in patients with Alagille syndrome (ALGS) treated with… read more.

Arcutis and Sato announce strategic collaboration and licensing agreement for topical roflumilast in Japan

Written by | 4 Mar 2024

Arcutis Biotherapeutics, Inc. and Sato Pharmaceutical Co., Ltd., a leading pharmaceutical company, announced that the companies have entered into a strategic collaboration and licensing agreement for the development,… read more.

BLA application for Tevimbra (tislelizumab) for first-line gastric or gastroesophageal junction cancers accepted by FDA – BeiGene

Written by | 3 Mar 2024

BeiGene, Ltd. announced that the FDA has accepted a Biologics License Application (BLA) for Tevimbra (tislelizumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients… read more.

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