Latest Biotech News

Roche is discontinuing two Huntington’s disease antisense programs in collaboration with Ionis, citing missed efficacy and safety-driven trial stops. In a letter to the Huntington’s disease...

The FDA has restarted the public release of complete response letters (CRLs), citing a renewed “commitment to transparency,” according to BioCentury. A new batch of rejection letters includes a...

GSK said its China Phase 3 readout for the B7-H3 antibody-drug conjugate risvutatug rezetecan (ris-rez), partnered with Hansoh Pharma, met its primary endpoint of overall survival in advanced or...

HHS unveiled “Operation Trialblazer,” a set of initiatives aimed at speeding early drug development while improving patient access and participation. The blueprint, described as spanning multiple...

Freenome reported updated clinical validation results for its SimpleScreen CRC blood test, describing improved detection of advanced precancerous lesions while overall sensitivity dipped modestly...

ARPA-H announced THRIVE, a program funding up to $160 million to advance bespoke gene-editing therapies for rare diseases into the clinic. The effort includes seven teams pursuing different rare...

A Phase I/II trial led by researchers at Skåne University Hospital and Lund University reported that transplantation of stem-cell-derived dopamine progenitor cells is feasible and was not linked...

Researchers from University of Rochester Medicine and the University of Copenhagen reported a delivery strategy intended to overcome two persistent gene therapy hurdles—blood-brain barrier...

Natera said its Signatera minimal residual disease (MRD) platform has received IVDR certification for multiple cancers. The certification review covered the assay, specimen collection kit, and...

Biopharma leaders are revisiting how to operationalize AI in discovery and development after McKinsey argued that AI value won’t “compound learning” unless companies redesign R&D around...

The FDA posted 14 new drug rejection letters (CRLs) online, resuming public releases after prior pauses tied to litigation risk and heightened sensitivity around CRL content. The agency’s updated...

AstraZeneca and Ionis reported a major Phase 3 setback for eplontersen (Wainua) in transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), with the gene-silencing therapy failing to outperform...

GSK said its B7-H3-targeted ADC risvutatug rezetecan (ris-rez), partnered with Hansoh, met the Phase 3 primary endpoint of overall survival in advanced or relapsed small-cell lung cancer in China....

Freenome’s updated SimpleScreen CRC blood test met primary and secondary endpoints in a large clinical validation study drawn from the prospective PREEMPT CRC registry and additional blinded...

Researchers reported first human outcomes for STEM-PD, a Phase 1/2 open-label trial of cryopreserved, off-the-shelf dopaminergic progenitor cells derived from human embryonic stem cells for...

Roche told patient groups it is ending two Huntington’s disease development programs, including the Ionis-partnered antisense drug tominersen (Phase 2) after efficacy disappointment and its...

ARPA-H announced THRIVE, a $160 million effort to accelerate custom gene-editing therapies into the clinic for rare genetic pediatric diseases. The program will fund seven teams using diverse...

A study in the Journal of Nuclear Medicine reported that repeating PSMA PET imaging after an initial negative scan changed treatment decisions for nearly half of patients with prostate cancer...

IKS Health agreed to acquire TruBridge for $557 million, folding the rural-hospital-focused EHR and revenue cycle company into its AI-powered care platform. The deal marks IKS’ third acquisition...

En Carta Diagnostics raised €5 million ($5.7 million) in private financing to advance its aptamer-based molecular platform, including its EC Pocket Lyme point-of-care test. The funding includes €3...