Jun 05, 2026
Key oncology developments include a $315 million partnership between Astellas and Vir for the prostate cancer T-cell engager VIR-5500, with updated phase 1 data showing an 82% PSA50 rate. The FDA accepted a filing for Ono Pharmaceuticals' tirabrutinib seeking accelerated approval in primary central nervous system lymphoma. Research findings also identified a new kidney cancer biomarker and showed promising results for the TRK inhibitor repotrectinib and the breast cancer triple therapy gedatolisib plus palbociclib and fulvestrant.
Apr 17, 2026
The Middle East and Africa biosimilars market is estimated to grow from USD 1.15 billion to USD 5.73 billion by 2035 at a 19% CAGR. Monoclonal antibodies hold almost 55% of market share, while oncological disorders dominate demand.
Feb 19, 2026
Zenyaku Kogyo obtained Japanese regulatory approval for Rituxan (rituximab) as a treatment for autoimmune hemolytic anemia, a government-designated intractable disease. The approval follows a public knowledge-based application submitted in August 2025.
Feb 18, 2026
The FDA has accepted a new drug application for tirabrutinib, a BTK inhibitor, for relapsed/refractory primary central nervous system lymphoma under the accelerated approval pathway. The regulatory agency set a PDUFA target action date of December 18, 2026.
Feb 13, 2026
Dr Reddy's and Biocon plan to launch generic versions of Novo Nordisk's weight-loss drugs at up to 60% below branded prices as semaglutide patents expire, targeting a global market projected to reach $150 billion by the early 2030s.
