Read our latest updates & insights

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...

AIS Health reports that, on 1 January 2025, Amgen launched Wezlana® (ustekinumab), biosimilar to J&J/Janssen’s Stelara® in the US through Optum Health Solution’s private label subsidiary Nuvaila.

Wezlana® was the first interchangeable ustekinumab biosimilar appro...

On 1 January 2025, Sandoz’s high concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab) was listed on Australia’s Pharmaceutical Benefits Scheme (PBS) in a 40 mg/0.4 mL injection, 2 x 0.4 mL pen formulation for the same indications as Humira®.

Hyrimoz® (...

On 30 December 2024, Johnson & Johnson (J&J) announced that the European Commission has approved a Type II variation extension of indication for its Rybrevant® (amivantamab) as combination therapy with Lazcluze® (lazertinib) for the first-line treatment of adult pat...

On 27 December 2024, BMS announced that the US FDA has granted approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use, a combination product of nivolumab co-formulated with recombinant human hyaluronidase (rHuPH20).  The approval cove...