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On 27 November 2024, Novo Nordisk Canada announced Canadian approval of Wegovy® (semaglutide)  for the reduction of risk of non-fatal myocardial infarction in adults with established cardiovascular disease.   

Wegovy® was approved in Canada for the treatment of obesi...

On 26 November 2024, CSPC Pharmaceutical Group Limited (CSPC) announced that its biologic license application for ustekinumab (biosimilar to Johnson & Johnson’s Stelara®) was accepted by the People’s Republic of China’s National Medical Products Administration (NM...

On 26 November 2024, Celltrion’s Omlyclo®, biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab) was approved in Australia.  Omlyclo® is the first omalizumab biosimilar approved in Australia. 

Omylclo® was approved in Australia for two presentation...

On 26 November 2024, The Economic Times reported that AstraZeneca has received approval from India’s Central Drugs Standard Control Organisation (CSDCO) to market Lynparza® (olaparib) in India.  

The CDSCO granted approval for the use of Lynparza® in combinatio...

On 25 November 2024, GlaxoSmithKline (GSK) announced that the FDA has accepted its BLA for Blenrep® (belantamab mafodotin) in combination with BorDex (bortezomib plus dexamethasone) or PomDex (pomalidomide plus dexamethasone) for the treatment of patients with multiple myel...

On 22 November 2024, Chugai (a Roche subsidiary) and Zenyaku Kogyo announced that their co-marketed Rituxan® (rituximab) has been approved by the Japanese Ministry of Health, Labour and Welfare for chronic idiopathic thrombocytopenic purpura (ITP) in children (IV injection,...

On 22 November 2024, Johnson & Johnson submitted a supplemental Biologics License Application to the FDA seeking approval of a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis ...

On 22 November 2024, Celltrion announced that the Korean Ministry of Food and Drug Safety has approved its Stoboclo™ (CT-P41, denosumab) and Osenvelt™ (CT-P41, denosumab), biosimilars to Amgen’s Prolia® and Xgeva®, respectively.

Stoboclo™ and Osenvelt™ are the first ...