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Genentech announced that FDA has approved Xolair® for the reduction of allergic reactions, including anaphylaxis, in adult and paediatric patients aged 1 year and older with IgE-mediated food allergy.  The announcement states that Xolair® is the first FDA-approved medicine ...

Regeneron and Sanofi announced that they have received approval in Japan for Dupixent® (dupilumab) for the treatment of Chronic Spontaneous Urticaria (CSU) in people aged 12 and older whose disease is not adequately controlled with existing therapy.  Approval followed a pha...

Alvotech announced that it has settled with Johnson & Johnson in the European Economic Area (EEA), Japan and Canada for its ustekinumab biosimilar, AVT04, and has provided guidance on its proposed launch dates in these regions.  AVT04 received regulatory approval in Jan...

BMS announced that the FDA has accepted a priority review for its Augtyro® (repotrectinib) for the treatment of patients 12 years of age and older with solid tumours that have neurotrophic tyrosine receptor kinase (NTRK) gene fusion and are locally advanced or metastatic, o...

On 14 February 2024, Galderma announced that the FDA accepted its Biologics License Applications, and the EMA accepted its Marketing Authorization Applications, for use of nemolizumab in the treatment of patients with prurigo nodularis and atopic dermatitis. Galderma plans ...

On 13 February 2024, Korea IT Times reported that Celltrion has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for CT-P47, biosimilar to Actemra® (tocilizumab).    

This follows the announcement by Celltrion at the end of Janua...

A study sponsored by Qilu Pharmaceutical, published in Ophthalmology and Therapy reports that, in a Chinese, randomised, double-blind, phase III trial, Qilu’s QL1207 was equivalent to Regeneron’s Eylea® for neovascular age-related macular degeneration, with similar safety p...

A paper published in the journal BioDrugs reported the results of a Phase III study conducted in Eastern Europe and the Republic of Korea comparing the efficacy, safety, pharmacokinetics and immunogenicity of Celltrion’s CT-P43 with Janssen’s Stelara® (ustekinumab).  The st...

On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals regarding the Patent Trial and Appeal Board’s (PTAB) decision in IPR2022-00578 and IPR2022-00579.  The motion records that Celltrion (the petitioner) has n...