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Sandoz launches Pyzchiva autoinjector, first commercially available in Europe for ustekinumab biosimilars

Written by | 19 Jul 2025

Sandoz announced the European launch of its Pyzchiva (ustekinumab) autoinjector. This is the first ustekinumab biosimilar in Europe commercially available in an autoinjector. Developed and registered by Samsung… read more.

Nucala (mepolizumab) approved by US FDA for use in adults with chronic obstructive pulmonary disease – GSK

Written by | 18 Jul 2025

GSK plc announced that the FDA has approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype. FDA’s approval… read more.

Roche receives CE Mark for its Chest Pain Triage algorithm to enhance detection of acute coronary syndrome

Written by | 17 Jul 2025

Roche announced the introduction of its innovative Chest Pain Triage algorithm as part of the navify  Algorithm Suite. This groundbreaking algorithm is designed to more quickly and accurately… read more.

Johnson & Johnson MedTech highlights stroke care pipeline, MIGRAINE study at SNIS 2025

Written by | 15 Jul 2025

Johnson & Johnson MedTech, a leader in neurovascular care, announced today its upcoming data presentations and onsite activities at the 2025 Society of NeuroInterventional Surgery (SNIS) 22nd Annual Meeting &… read more.

FDA approves Avtozma (tocilizumab-anoh) in both an intravenous and subcutaneous formulation as a biosimilar to Actemra – Celltrion

Written by | 14 Jul 2025

Celltrion announced that the FDA has approved Avtozma (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to Actemra. Avtozma is indicated for… read more.

Cytokinetics showcases Five Aficamten presentations at ESC Congress 2025

Written by | 12 Jul 2025

Cytokinetics, Incorporated (announced five presentations related to aficamten at the European Society of Cardiology Congress 2025 taking place in Madrid, Spain from August 29, 2025 – September 1,… read more.

CHMP adoptes positive opinion, for Tepezza (teprotumumab) for treatment of adults with moderate to severe thyroid eye disease – Amgen

Written by | 12 Jul 2025

The EMA has recommended granting a marketing authorisation in the European Union (EU) for Tepezza (teprotumumab), for the treatment of adults with moderate to severe thyroid eye disease…. read more.

Positive CHMP opinion for Bosulif (bosutinib) on variation to marketing authorisation to extend the use of Bosulif to children aged 6 years and older – Pfizer

Written by | 11 Jul 2025

The Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Bosulif…. read more.

OPKO and Entera to present oral GLP-2 analog for SBS at ESPEN 2025

Written by | 10 Jul 2025

OPKO Health, Inc and Entera Bio Ltd announced that their abstract “First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome” has been selected for a poster presentation… read more.

Tremfya (guselkumab) delivers sustained clinical and endoscopic remission in ulcerative colitis through two years – Johnson & Johnson

Written by | 10 Jul 2025

Johnson & Johnson announced new data from the Tremfya (guselkumab) Phase III QUASAR long-term extension (LTE) study in adults with moderately-to-severely active ulcerative colitis (UC). Data from the… read more.

Eylea (aflibercept) 8 mg approved in China for wet age-related macular degeneration – Bayer

Written by | 9 Jul 2025

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved Eylea 8 mg (aflibercept 8 mg) for the treatment of neovascular (wet) age-related… read more.

CHMP positive recommendation for Amvuttra (vutrisiran) for the treatment of ATTR amyloidosis with cardiomyopathy – Alnylam Pharma

Written by | 8 Jul 2025

Alnylam Pharmaceuticals Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted a positive opinion recommending approval of its RNAi therapeutic… read more.

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