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On 22 April 2026, Amneal Pharmaceuticals and Kashiv BioSciences jointly announced that Amneal will acquire 100% of Kashiv BioSciences.  The deal (which is subject to approval by Amneal shareholders and regulatory authorities) is expected to close in the second half of 2026....

On 22 April 2026, Regeneron and Sanofi announced that Dupixent® (dupilumab) has been approved by the FDA for the treatment of children aged 2 to 11 years with chronic spontaneous urticaria (CSU) and inadequate response to histamine-1 antihistamine (H1AH) treatment.  This ap...

On 17 December 2025, Bristol Myers Squibb announced that Canada’s Drug Agency (CDA-AMC) has issued a positive reimbursement recommendation for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for the first-line treatment of adult patients with unresectable or me...

On 21 April 2026, Celltrion announced that the intravenous (IV) formulation of Steqeyma® (ustekinumab), biosimilar to Janssen’s Stelara®, has been approved in Japan.  The newly approved formulation adds to Celltrion’s subcutaneous (SC) formulation of Steqeyma®, which was la...

On 21 April 2026, Roche announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of systemic lupus erythematosus (SLE).  According to Roche, if Gazyva®/Gazyvaro® is approved, it will be ...

On 21 April 2026, Biocon announced that, on 3 April 2026, Health Canada approved Bosaya™ and Vevzuo™, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively.  Bosaya™ is approved as a 60mg/mL PFS, while Vevzuo™ is approved as a 120 mg/1.7mL single-dose vial.  No...

On 20 April 2026, PR Newswire reported that Health Canada has approved JAMP Pharma’s Upgolyv™, biosimilar to Janssen’s Simponi® (golimumab), for the treatment of chronic inflammatory autoimmune diseases.  Upgolyv™ is the first golimumab biosimilar to be approved...

On 20 April 2026, Astellas Pharma and Pfizer announced that the FDA granted priority review of the sBLA for Astella Pharma/Pfizer’s Padcev™ (enfortumab vedotin-ejfv) in combination with MSD’s Keytruda® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase a...

On 17 April 2026, Samsung Bioepis announced new clinical data reinforcing the efficacy of its denosumab biosimilar, SB16 (Obodence®, referred to in the US as Ospomyv®), and highlighting consistent outcomes across diverse patient subgroups.  The findings were presented at th...