Latest Biotech News

Roche moved to end two Huntington’s disease trials tied to Ionis, discontinuing the Phase 2 GENERATION HD2 study of tominersen after the asset failed its key efficacy objective, and also stopping...

The FDA resumed posting complete response letters (CRLs) after a reported pause, posting 14 new rejection letters in a single batch. The agency cited “commitment to transparency,” according to the...

The FDA again rejected a liver cancer regimen combining Hengrui’s camrelizumab and Elevar Therapeutics’ rivoceranib, marking the third CRL for the program. The latest setback was attributed to...

Germany’s federal parliament advanced a cost-saving bill that biopharma groups say could push drugmakers out, including a jump in mandatory manufacturer rebates. The legislation would raise the...

GSK said a Phase 3 study in China of its B7-H3-targeted antibody-drug conjugate risvutatug rezetecan (ris-rez) met its primary endpoint of overall survival in advanced or relapsed small-cell lung...

Quest Diagnostics began integrating its Haystack MRD ctDNA test and comprehensive genomic profiling into Flatiron Health’s OncoEMR electronic health record system through an opt-in ordering...

Freenome reported that an updated version of its SimpleScreen CRC blood test met primary and secondary endpoints in a clinical validation study, but stakeholders reacted as mixed. The study used...

ARPA-H announced teams for its THRIVE program—Treating Hereditary Rare Diseases with In Vivo prEcision genetic medicines—with a commitment of up to $160 million over five years. The initiative is...

Fate Therapeutics received FDA IND clearance for FT-839, its next-generation off-the-shelf CAR T-cell candidate targeting CD19 and CD38 for autoimmune diseases. The clearance moves the program...

En Carta Diagnostics raised €5 million in private financing, including €3 million in equity investments and €2 million in nondilutive funding from Bpifrance and others. The funding is aimed at...

Roche has discontinued two Ionis-partnered antisense therapy programs in Huntington’s disease after failing to meet key efficacy and safety objectives. In a letter to Huntington’s disease...

A Phase 3 readout for AstraZeneca and Ionis’ Wainua (eplontersen) has failed in transthyretin amyloid cardiomyopathy, further constricting development options for TTR-silencing approaches in...

The FDA has resumed issuing complete response letters (CRLs) to pharmaceutical companies after citing a renewed focus on transparency, according to reporting on newly posted decision letters. The...

The FDA has rejected an investigational liver cancer regimen combining HLB Co.’s rivoceranib with Jiangsu Hengrui’s camrelizumab for a third time, citing manufacturing deficiencies tied to a...

GSK and Hansoh reported Phase 3 success in China for risvutatug rezetecan (ris-rez), a B7-H3-targeted antibody-drug conjugate in advanced or relapsed small cell lung cancer. The program met its...

McKinsey released analysis arguing that biopharma firms need a structural redesign to turn AI-driven workflows into compounding learning rather than isolated efficiency gains. The report describes...

New Nature Biotechnology findings report a more efficient in vivo cytosine base editing strategy using virus-like particles alongside uracil DNA glycosylase inhibition. The work focuses on...

Stanford researchers unveiled Biomni, an AI biomedical agent designed to function as an “expert collaborator” that can autonomously read literature, analyze data, write code, and plan experimental...

Freenome reported clinical validation data for an updated SimpleScreen CRC blood test, with results based on blinded previously unevaluated samples from the prospective PREEMPT CRC study and...

Clinical development in Parkinson’s regeneration advanced as reports highlighted feasibility and early safety signals from stem-cell-derived dopaminergic cell transplantation. A Phase I/II...