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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...
Telix NDA acceptance for radiolabeled glioma imaging
The U.S. FDA accepted Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px (Pixclara), a radiolabeled imaging agent for characterizing progressive or recurrent glioma in both adult and pediatric...
Avalyn eyes IPO to fund inhaled IPF Phase 3
Avalyn Pharma is exploring an IPO to fund Phase III development of inhaled therapies for pulmonary fibrosis, according to an SEC filing. The company’s lead candidate, AP01, is an inhaled...
Realta raises more capital for hypoxic ischemic encephalopathy treatment
Realta Life Sciences secured an additional $40 million in the final tranche of its Series A financing, lifting total funding to more than $150 million. The company is developing a treatment for...
Emerging engineered cell therapy cybersecurity claim
A new DNA encryption approach is being reported as a way to protect engineered cells from tampering and theft by securing biological information “from within.” The work frames protection as part...
Biopharma operational tools: cryo-EM expansion for antibody discovery
FairJourney Bio opened a cryo-electron microscopy (cryo-EM) structural biology facility in San Diego, expanding the company’s U.S. presence and adding atomic-resolution structure capability...
CAR T safety strategy via receptor affinity tuning
Researchers reported a CAR T-cell optimization strategy that modulates receptor affinity to balance efficacy and safety. Instead of using a single fixed binding strength, the approach aims to...
Immunotherapy mechanism discovery in AML
A multi-institution team identified a novel immune evasion mechanism in acute myeloid leukemia centered on the glycoprotein CD43, described as a “don’t eat me” signal. The research, published in...
Telomere- and inflammation-linked neurobiology tool: MARCH2 protects from doxorubicin injury
A study in Nature Communications identified MARCH2 as a key molecular protector against chemotherapy-induced heart damage from doxorubicin. The work describes how MARCH2 stabilizes cardiac cells...