Latest Biotech News

The FDA rejected Replimune’s oncolytic virus therapy RP1 for melanoma for a second time, underscoring persistent regulatory concerns around the trial data. The agency said the company failed to...

Oricell Therapeutics raised more than $110 million in a pre-IPO round to expand its solid-tumor CAR-T program, betting that armored autologous approaches can overcome the immune suppression common...

A phase 2 trial reported that mezagitamab, an investigational antibody, significantly increased platelet counts in patients with immune thrombocytopenia (ITP). ITP is driven by immune-mediated...

The FDA accepted Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px (Pixclara), a radiolabeled glioma imaging agent using 18F-floretyrosine (18F-FET). The agency assigned a Sept. 11, 2026 PDUFA...

Realta Life Sciences secured an additional $40 million in the final tranche of its Series A, bringing total raised to more than $150 million for its hypoxic ischemic encephalopathy (HIE)...

Gilead Sciences exercised an option to exclusively license KT-200, an oral CDK2 molecular glue degrader program developed by Kymera Therapeutics. The move expands Gilead’s strategy in targeted...

FairJourney Bio opened a new cryo-EM structural biology facility in San Diego to expand its antibody discovery capabilities with atomic-resolution services. The site includes two ThermoFisher...

Agilent Technologies highlighted how lab automation and new instrumentation can scale antibody-drug conjugate (ADC) characterization for faster and more reproducible development. The focus is on...

A study in Cell Death & Discovery described how CX3CR1-dependent immune networks can shape sepsis progression. The research led by Tang et al. focuses on a chemokine receptor that helps coordinate...

A newly published charter for the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) expands vaccine-safety monitoring as a primary function and reshapes membership criteria after a...

Oricell Therapeutics moved closer to solid-tumor CAR-T commercialization with a $110 million pre-IPO round earmarked for a GPC3-targeted autologous CAR-T in hepatocellular carcinoma. The funding...

The acting CDC director delayed publication of a study in the agency’s Morbidity and Mortality Weekly Report (MMWR) that was expected to quantify COVID-19 vaccine effectiveness against severe...

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,...

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...

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...

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...

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...

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,...

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...

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...