Latest Biotech News

The FDA posted a fresh batch of complete response letters, extending its recent run of detailed rejection feedback to drugmakers. Separate reporting also describes the agency resuming CRL releases...

Roche shut down two Huntington’s disease studies tied to Ionis, ending the Phase 2 GENERATION HD2 antisense program after tominersen missed a key efficacy objective. Roche also stopped a separate...

New preclinical cancer biology work in the British Journal of Cancer connects TP53 mutations in urothelial carcinoma to CD8+ T cell exhaustion and therapy resistance. The study describes how...

A JAMA study reports the YEARS diagnostic algorithm performs on par with standard CTPA imaging for suspected pulmonary embolism in cancer patients while reducing the number of patients who need...

Freenome reported clinical validation results for its updated SimpleScreen CRC blood test, saying the platform met primary and secondary endpoints. The study used blinded, previously unevaluated...

Researchers unveiled SpudCell as a step toward building cell-like systems from non-living components, reporting the creation of a synthetic cell-like structure assembled from purified, nonliving...

Researchers presented early human clinical work exploring an immune-engineered, allogeneic insulin-producing cell therapy approach for type 1 diabetes at the ISSCR 2026 Annual Meeting. The program...

Texas A&M researchers, led by Dr. Arum Han, secured NIH funding for a new organ-on-a-chip center aimed at improving chemical safety testing and potentially reducing reliance on animal studies. The...

A new approach for real-time pathogen tracking uses wastewater analysis to estimate transmission dynamics, aimed at surveillance without relying solely on clinical reporting. The method, described...

Germany’s federal parliament passed a cost-saving drug policy that doubles mandatory manufacturer rebates on many brand-name prescriptions from 7% to 15.5%. The legislation also raises discount...

Roche moved to shut down two Huntington’s disease antisense programs developed with Ionis Pharmaceuticals after disappointing efficacy signals. In a letter to the Huntington’s community, Roche...

The FDA restarted the flow of pharma complete response letters (CRLs), posting 14 new rejection letters online. The agency’s return to publishing these decisions follows an earlier pause tied to...

The US FDA rejected a liver cancer combination from Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics for the third time, according to reporting. The regimen combines HLB’s rivoceranib with...

Germany’s lawmakers approved a cost-saving bill that would more than double mandatory manufacturer rebates on many branded prescription drugs from 7% to 15.5%. The package would also set a 9%...

GSK reported that its China Phase 3 study of a B7-H3 antibody-drug conjugate hit the main endpoint in advanced or relapsed small cell lung cancer. The experimental ADC, risvutatug rezetecan...

Analysts and investors focused on the apparent lack of synergy behind AstraZeneca and Ionis’ knockdown-and-stabilizer strategy after the Phase 3 fizzle in transthyretin amyloid cardiomyopathy....

Freenome announced that an updated version of its SimpleScreen CRC blood test met primary and secondary endpoints in a clinical validation study, drawing mixed stakeholder reaction. The analysis...

Researchers at the University of California, Santa Cruz (UCSC) are developing a nanopore-based RNA liquid biopsy intended for early cancer detection. The work centers on validating the Locate-seq...

ARPA-H announced the teams for its THRIVE program, committing up to $160 million over five years to accelerate bespoke in vivo precision genetic medicines for rare genetic pediatric diseases. The...

CARB-X is backing NeoTest, a Center for Global Development program designed to bridge neonatal sepsis diagnostics from development to market. Reporting said the initiative includes a proposed...