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On 18 October 2024, Astellas Pharma announced that the FDA has approved Vyloy™ (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic huma...

At its October 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for Novo Nordisk’s Alhemo® (concizumab) for routine prophylaxis of bleeding in patients of 12 years of age or more...

On 17 October 2024, Fresenius Kabi announced its Canadian launch of Tyenne®, biosimilar to Roche’s Actemra® (tocilizumab), in both IV and subcutaneous formulations. Tyenne® is indicated for the treatment of several inflammatory and immune diseases, including rheumatoid arth...

At its October meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Accord HealthCare’s, Imuldosa® (DMB-3115) and Absimky® (DMB-3115), biosimilars to Janssen’s Stelara® (ustekinumab).  Both biosim...

On 16 October 2024, Australia’s Therapeutic Goods Administration (TGA) reported its decision not to register Leqembi® (lecanemab) for the treatment of patients with mild Alzheimer’s dementia (early Alzheimer’s disease) and mild cognitive impairment (MCI) due to ...

On 16 October 2024, Formycon announced that results of a comparative analytical evaluation of its FYB206, published in Drugs in R&D, showed FYB206 to be structurally and functionally “highly similar” to MSD’s Keytruda® (pembrolizumab).

FYB206 is currently being e...

On 16 October 2024, the Economic Times reported that the Delhi High Court has reinstated an injunction preventing Zydus from manufacturing, selling or marketing Sigrima™, biosimilar to Roche’s Perjeta® (pertuzumab).

The 16 October 2024 decision of the Delhi High Cour...

On 16 October 2024, Chinese insulin maker Gan & Lee Pharmaceuticals reported its development of an injectable GLP-1 agonist, GZR18, which it claims has outperformed Novo Nordisk’s Ozempic® (semaglutide) in reducing glycated haemoglobin (HbA1c) and body weight in a...

On 15 October 2024, Johnson & Johnson (J&J) reported its results for Q3 2024, which saw sales growth of 5.2% to $22.5B. J&J’s significant regulatory announcements this quarter include applications for expanded US and EU indications of Darzalex® (daratumumab) and...