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Otsuka touts new IgAN evidence as it seeks full approval for Voyxact

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Otsuka is highlighting new 12‑month kidney‑function data from the Phase 3 VISIONARY trial to support a full approval application for Voyxact (sibeprenlimab) in IgA nephropathy (IgAN). VOYXACT demonstrated an increase in mean change for estimated glomerular filtration rate (eGFR) from baseline of +0.7 mL/min/1.73 m² compared to a decline of -4.8 mL/min/1.73 m² in the placebo‑treated group over 12 months. VOYXACT currently has U.S. FDA accelerated approval based on reduction of proteinuria, and continued approval is contingent on confirming clinical benefit in the ongoing VISIONARY trial. Sources: Otsuka Receives FDA Accelerated Approval for VOYXACT ... Otsuka Presents Positive Interim Phase 3 VISIONARY eGFR Data ... Otsuka Pharmaceutical's VOYXACT Gains Early Traction in IgAN ... Otsuka kidney drug slowed loss of function, but less than expected ... Primary IgAN Treatment | VOYXACT® (sibeprenlimab-szsi) Otsuka Showcases New Efficacy and Safety Data of VOYXACT ... ...

Innovent declares Phase 3 success for gastric cancer ADC that attracted huge Takeda deal

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Lilly and Novo Face Off at ADA 2026 as Others Seek to Compete in Obesity

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Lupin Receives U.S. FDA Approval for Ranluspec™ (ranibizumab) Injection: Interchangeable Biosimilar for Eye Diseases Now Cleared in the U.S.

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Supreme Court sides with Hikma in 'skinny label' case

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Acting FDA chief isn't interested in permanent role: Key facts Kyle Diamantas, an attorney who previously led the FDA's food program, has been named acting commissioner of the Food and Drug Administration following the resignation of Commissioner Marty Makary. Diamantas is stepping in on an interim basis while the administration searches for a permanent replacement, who will need to be nominated by the President and confirmed by the Senate. Reports indicate that Diamantas is viewed as a steady hand to manage the agency through this transition. There is no indication that Diamantas is seeking the permanent role, suggesting that he is not interested in becoming the next permanent FDA commissioner.

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Medline Faces FDA Warning Over Repeat *Bacillus cereus* Contamination in Drug Products

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Alnylam and Inceptive Form Strategic AI Collaboration to Accelerate the Discovery of RNAi Therapeutics

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Parabilis preps $413M IPO to fuel desmoid tumor drug into phase 3

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ADC Therapeutics shares sink over 50% after Phase 3 Zynlonta trial shows more deaths than standard therapy

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As China biotech crackdown calls reverberate in Washington, the pushback gets louder, too Recent efforts in Washington to restrict U.S. investment and partnerships with Chinese biotech firms have triggered a fierce backlash from industry leaders and intensified concerns in Beijing, turning biotech into the latest front in the U.S.-China tech rivalry.

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AbbVie’s QULIPTA and Amgen’s Imdylltra Score New EU Approvals for Migraine and Lung Cancer Indications

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Real-world patterns of Alzheimer’s disease biomarker testing: Insights from a large-scale clinical dataset (Overview, 2026)

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