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FDA review and turnaround for cell therapy in cancer imaging
Telix Pharmaceuticals’ radiolabeled glioma imaging agent moved forward after the FDA accepted the company’s resubmitted NDA. The agency accepted TLX101-Px—marketed as Pixclara,...
Immunotherapy engineering: dual CAR-T to limit escape and rejection
Researchers reported a CAR-T strategy designed to address two persistent barriers to broader allogeneic use: antigen escape and alloimmune rejection. The approach pairs allogeneic CD19 CAR T cells...
Regenerative and translational approaches to organ injury and inflammation
Two translational science threads drew attention for their focus on tissue injury mechanisms. In experimental cardiac injury biology, researchers highlighted how MARCH2 helps guard cardiac cells...
Biomarker innovation in neurodegeneration
A new plasma biomarker approach is aiming to connect amyloid biology with synuclein-driven neurodegeneration. In npj Parkinson’s Disease, researchers identified plasma phosphorylated tau 217...
Early detection and AI diagnostics for Parkinson’s
Two separate AI-enabled paths for Parkinson’s diagnosis and risk stratification surfaced. A machine learning method published in npj Parkinson’s Disease classifies individuals with Parkinson’s who...
Clinical and biologics development updates: antibody efficacy and manufacturing infrastructure
A phase 2 signal highlighted antibody performance in immune thrombocytopenia (ITP). The investigational antibody mezagitamab significantly increased platelet counts in patients in a Phase 2 trial,...
Cardiometabolic and renal mechanism research
Multiple mechanistic biology reports focused on cardio-renal risk pathways. One study in Cell Death Discovery examined how PPAR signaling shapes diabetic kidney disease development, mapping roles...
Diagnostic scale-up in genomics and lab infrastructure
MGI Tech received China NMPA approval for its DNBSeq-T1+ sequencer, clearing the platform for deployment into the Chinese clinical market. MGI said the benchtop system can produce up to 1.2...
FDA drug review reversals in melanoma cell therapy
The FDA rejected Replimune Group’s oncolytic virus therapy for advanced melanoma for a second time, according to separate coverage of the agency’s latest decision. The company’s therapy,...
FDA regulatory acceptance for glioma imaging agent
Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px has been accepted for FDA review, with a scheduled PDUFA date of Sept. 11, 2026. The radiolabeled glioma imaging agent (Pixclara;...
Takeda board changes and CEO transition
Takeda announced leadership and governance changes ahead of its upcoming shareholders meeting, including new candidates for the board of directors and a change in the representative director. The...
Oricell pre-IPO funding to push solid-tumor CAR T toward pivotal trials
Oricell Therapeutics closed a $110 million pre-IPO round to expand its footprint and advance a GPC3-targeted autologous CAR T therapy for liver cancer. The company’s Ori-C101 is expected to move...
New financing for hypoxic ischemic encephalopathy treatment
Realta Life Sciences secured an additional $40 million in the final tranche of its Series A, bringing total funding to more than $150 million. The biotech is developing a treatment for hypoxic...
Biopharma product safety and evidence standards in vaccine policy oversight
The charter for the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) adds emphasis on vaccine safety and expands membership criteria, after a judge suspended many Trump...
Rapid growth in CAR-T and antigen escape mitigation strategies
Researchers reported a dual-target strategy using allogeneic CD19 CAR T cells augmented with an anti-rejection CD70 CAR to address both antigen escape and alloimmune rejection barriers. The...
Phase 2 signal for rapid-acting ITP antibody
A Phase 2 trial in immune thrombocytopenia reported that mezagitamab significantly increased platelet counts in affected patients, according to the coverage. In ITP, patients experience low...
New high-throughput MDM2 approach for radiation-resistant uveal melanoma
Scientists unveiled a high-throughput strategy to target MDM2 in an effort to overcome radiation resistance in uveal melanoma. The work frames radiation therapy resistance as a key barrier for...
Scalable cryo-EM structural biology expansion for antibody discovery
FairJourney Bio opened a cryo-electron microscopy structural biology facility in San Diego to expand its antibody discovery capabilities, with services launched in January 2026. The new site...
FDA actions on melanoma oncolytic virus program
Replimune’s oncolytic virus therapy for advanced melanoma was rejected by the FDA for a second time after the company resubmitted an application following earlier concerns. The agency said...
Oricell pre-IPO funding to scale solid-tumor CAR-T
Oricell Therapeutics closed a $110 million pre-IPO round to expand its solid-tumor CAR-T pipeline, with proceeds intended to push its GPC3-targeted autologous CAR-T for liver cancer toward...