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Industry & Policy News

Uplizna® (Inebilizumab-Cdon) Is Now the First and Only FDA-Approved Treatment for IGG4-Related Disease

[Amgen] Amgen announced that the US FDA has approved UPLIZNA as the first and only treatment for adults living with Immunoglobulin G4-related disease (IgG4-RD).

European Commission Approves Johnson & Johnson’s Subcutaneous DARZALEX® (Daratumumab)-based Quadruplet Regimen for the Treatment of Patients with Newly Diagnosed Multiple Myeloma, Regardless of Transplant...

[ohnson & Johnson] Janssen-Cilag International NV, a Johnson & Johnson company, announced that the European Commission has approved an indication extension of DARZALEX® subcutaneous formulation in the frontline setting.

Trump Administration Quashes NIH Scientific Integrity Policy

[Science] The now-rescinded policy, designed to protect government researchers from political pressure, strongly endorsed DEI in science

IMFINZI® (Durvalumab) Approved in the US As First and Only Perioperative Immunotherapy for Patients with Muscle-Invasive Bladder Cancer

[Astrazeneca] AstraZeneca’s Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy has been approved in the US for the treatment of adult patients with muscle-invasive bladder cancer.

Yaqrit Secures NIHR Grant for Pivotal Trials of Its Liver Support Device, DIALIVE, for Patients with Liver Failure

[Yagrit (Globe Newswire)] Yaqrit announced a major £2.2 million clinical research grant that will fund the development of its extracorporeal liver support device, DIALIVE for advanced liver disease patients and move the device closer to UKCA and CE mark for marketing authorization.

Dupixent® (dupilumab) Approved as the First-ever Biologic Medicine in Japan for Patients with Chronic Obstructive Pulmonary Disease (COPD)

[Regeneron Pharmaceuticals, Inc. ] Regeneron Pharmaceuticals, Inc. and Sanofi announced that the Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent® for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy.

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