On 8 January 2025, Astellas Pharma announced that China’s National Medical Products Administration (NMPA) has approved its Padcev™ (enfortumab vedotin) in combination with Merck’s (known as MSD outside the US and Canada) Keytruda® (pembrolizumab) for adult patients with loc...
On 7 January 2025, Biocon announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved its subcutaneous ustekinumab (Bmab 1200), biosimilar to J&J/Janssen’s Stelara®. Biocon’s biosimilar ustekinumab will be commercialised and marketed in Japan ...
On 6 January 2025, the Australian Therapeutic Goods Administration (TGA) approved an indication expansion for BeiGene’s Tevimbra® (tislelizumab) in combination with platinum-based chemotherapy for the first-line treatment of patients with unresectable, locally advanced or m...
On 6 January 2025, the Therapeutic Goods Administration (TGA) provisionally approved AbbVie’s Epkinly® (epcoritamab) in 4mg/0.8mL concentrate solution and 48mg/0.8mL solution for injection vial, indicated for the treatment of adult patients with relapsed or refractory diffu...
On 3 January 2025, GSK announced that China’s National Medical Products Administration (NMPA) has approved Nucala® (mepolizumab) as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) f...
On 2 January 2025, the FDA published a Citizen Petition filed by Novo Nordisk seeking to exclude its type 2 diabetes liraglutide injection Victoza® from a proposed list of drugs eligible for compounding. In its petition, Novo Nordisk argues that there is no clinical need t...
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