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Feb 28, 2026
Bristol Myers Squibb reported fourth quarter and full year 2025 results that beat consensus expectations, with total revenues of $48.3 billion. The company announced FDA acceptance of its new drug application for iberdomide and positive Phase 2 results for Reblozyl.
Feb 24, 2026
The FDA accepted a new drug application for tirabrutinib to treat relapsed or refractory primary central nervous system lymphoma, with a decision expected December 18, 2026. The application is supported by phase 2 trial data showing a 67% overall response rate.
Feb 24, 2026
Rocket Pharmaceuticals will participate in two investor conferences in March 2026, with the CEO taking part in a fireside chat and management hosting investor meetings at both events.
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 16, 2026
Three comprehensive reports examine the monoclonal antibody landscape, covering CD47-targeted immunotherapy pipelines, competitive analysis of 180+ companies developing mAb therapeutics, and recombinant antibody market forecasts through 2033.
Oct 01, 2025
The FDA approved Zycubo (copper histidinate) on January 13, 2026, as the first treatment for Menkes disease in pediatric patients, following resolution of manufacturing compliance concerns that led to an initial rejection in September 2025.
Jan 16, 2026
The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen, for cancer patients at risk of infection due to chemotherapy and other indications. The approval marks Accord BioPharma's sixth biosimilar product.
Feb 12, 2026
The FDA approved pembrolizumab (Keytruda) and Keytruda Qlex plus paclitaxel, with or without bevacizumab, for adults with PD-L1+ platinum-resistant ovarian carcinoma based on Phase 3 trial data showing improved survival outcomes.
Dec 22, 2025
The FDA approved multiple denosumab biosimilars in late 2025 and issued REMS safety updates emphasizing severe hypocalcemia risk in patients with advanced chronic kidney disease, including reported hospitalizations and fatalities.
Feb 13, 2026
Novartis announced final Phase III ALIGN results showing Vanrafia slowed kidney function decline in adults with IgA nephropathy, supporting planned submissions for traditional approval in 2026 following accelerated approvals in the U.S. and China in 2025.
