Latest Biotech News

STAT+ reports that China is tightening oversight of clinical trials, even as U.S. stakeholders seek ways to match China’s historically faster pace. A key focus is on investigator-initiated trials...

STAT+ highlights growing safety concerns for radiopharmaceutical developers as more programs move into clinical trials. While the targeting premise remains that isotopes can deliver radiation more...

A Nature Communications study led by Zhou, Su, Liang and colleagues examines whether molecular residual disease (MRD) signals after surgery can guide care in early-stage, resected non-small cell...

Arpeggio Biosciences is disbanding after leadership concluded its Nrf2 small-molecule degrader program for non-small cell lung cancer could not separate efficacy from off-target liability. In an...

Eli Lilly shares rose after the company reported second-quarter results that beat analyst expectations, driven by continued revenue momentum from tirzepatide marketed as Zepbound for obesity and...

aTyr Pharma laid off 60% of its workforce as it conserves resources for a second shot at Phase 3 success in a lung disease program. The report indicates the company is taking cost-reduction steps...

Two debuting biotechs used IPOs to put fresh capital behind late-stage ambitions and targeted discovery programs. Latigo Biotherapeutics raised $346 million for a pipeline that includes a...

Braveheart Bio priced a large biotech IPO tied to a clinical-stage heart drug, positioning the company to build momentum ahead of key development milestones. The report says the Braveheart Bio...

An article focused on regulatory operations argues that submission readiness depends on more than compiling scientific evidence into an eCTD. It stresses that regulators can only evaluate what is...

A real-world study of nearly 5,000 men with metastatic hormone-sensitive prostate cancer suggests a specific prostate-specific antigen (PSA) milestone may better correlate with survival than...

Regulatory reviewers can only evaluate a marketing authorization application when it is translated into a complete, compliant, and internally consistent dossier. A new piece on submission...

China is tightening aspects of clinical trial oversight for investigator-initiated trials, even as U.S. stakeholders look to China’s earlier speed as a model. A STAT+ report says the system that...

Radiopharmaceutical developers are running into safety issues as more targeted agents move deeper into clinical trials. A STAT+ report describes how radioactive isotopes—though engineered to home...

A Nature Communications study ties declining liver integrity to adaptive β-catenin-driven tumorigenesis, spotlighting how tissue structure may actively enable cancer progression. The work, led by...

Researchers reported a new cancer-targeting strategy that combines bacterial tumor targeting, nutrient deprivation, and immune stimulation in a single engineered therapeutic. The approach uses a...

aTyr Pharma is cutting 60% of its workforce to fund a second phase 3 push for a lung disease drug after an initial failure. The report frames the move as a resource reallocation designed to...

A real-world analysis of nearly 5,000 men with metastatic hormone-sensitive prostate cancer points to a PSA threshold that may better predict outcomes than the typical percentage decline. The...

A nanoparticle pan-Ebolavirus vaccine protected rodents against lethal Zaire and Sudan virus infections, according to a Nature Communications study. Weidle, Brunette, Wrenn, and colleagues report...

Braveheart Bio raised about $382 million in an IPO, pushing total proceeds to nearly $440 million after underwriters exercised an option to buy additional shares. The company’s lead heart drug...

Latigo Biotherapeutics secured $346 million in an IPO to fund a pipeline of non-opioid pain drug candidates, including an asset planned for pivotal testing. The company said it will apply proceeds...