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FDA approval for Tevimbra for the treatment of advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy – BeiGene

Written by | 19 Mar 2024

BeiGene, Ltd. announced that the FDA has approved Tevimbra (tislelizumab-jsgr) as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after… read more.

Santhera’s partner Catalyst Pharmaceuticals launches Agamree (vamorolone) in the United States to treat Duchenne muscular dystrophy

Written by | 18 Mar 2024

Santhera Pharmaceuticals is pleased to note the launch of Agamree (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in the United States by Catalyst Pharmaceuticals, Inc. the… read more.

FDA approves Opdivo (nivolumab), plus cisplatin and gemcitabine, for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma – BMS

Written by | 17 Mar 2024

Bristol Myers Squibb announced that the FDA approved Opdivo (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial… read more.

Abbott recalls HeartMate Touch communication system for unintentional pump start and stop

Written by | 16 Mar 2024

The HeartMate Touch Communication System monitors patients who have an implantable HeartMate 3 Left Ventricular Assist Device. The HeartMate Touch Communication System works with the HeartMate System Controller…. read more.

Complete Response Letter for Hetlioz (tasimelteon) for insomnia characterised by difficulty with sleep initiation – Vanda Pharma

Written by | 15 Mar 2024

Vanda Pharmaceuticals Inc. announced that on March 4, 2024, it received a Complete Response Letter (CRL) from the FDA as part of its ongoing review of Vanda’s supplemental… read more.

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.

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