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Aug 26, 2026
FDA approved Imaavy (nipocalimab-aahu), the first treatment for warm autoimmune hemolytic anemia; 24% achieved durable hemoglobin responses vs 8% with placebo. Rilzabrutinib earned Breakthrough status.
Aug 07, 2026
FDA approved Viridian's Lumvoa (veligrotug-vvze) for thyroid eye disease on June 26, 2026; immediate U.S. launch followed. Q2 2026 cash stood at $982 million, and elegrobart BLA submission is on track for Q1 2027.
May 28, 2026
With over 170 antibody products approved globally, bioprocess studies aim to improve manufacturing. Optimized OPM-CHO media increased fed-batch productivity by >40%, while salt addition was evaluated to improve antibody pool filterability.
May 21, 2026
A systematic review and meta-analysis found high infection rates with teclistamab in relapsed/refractory multiple myeloma. Five studies showed pooled infection rates of 56.5% for any grade and 27.6% for grade 3 or higher.
Apr 29, 2026
Three FcRn inhibitors are approved for generalized myasthenia gravis, with a head-to-head trial of efgartigimod and nipocalimab underway. Emerging therapies including telitacicept, gefurulimab, and CAR-T cell therapy (KYV-101) show promise, while Immunovant's batoclimab failed TED trials.
Apr 23, 2026
The FDA accepted Hansa Biopharma’s BLA for imlifidase and set a PDUFA action date of Dec. 19, 2026. The filing is backed by Phase 3 ConfIdeS data showing statistically significant efficacy.
Mar 06, 2026
The FDA has accepted Hansa Biopharma's Biologics License Application for imlifidase, a desensitization treatment for highly sensitized adult kidney transplant patients with positive crossmatch against deceased donors, with a PDUFA date of December 19, 2026.
Feb 26, 2026
CAR T-cell therapy is delivering high remission rates for multiple myeloma patients, with improved handoff communication reducing infection risks. FDA-approved BCMA-targeting products show response rates from 72% to 98% in heavily pretreated patients.
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.
