Biotechnology

Hopes for a new Huntington's gene therapy face a major delay as the FDA rejects uniQure's current data and calls for a more rigorous, complex study.

Zymeworks lands $250M from Royalty Pharma in a non-dilutive deal, validating its cancer drug Ziihera and highlighting a new era of biotech financing.

With positive Phase 3 data for its first-in-class Stargardt disease drug and a massive new financing round, Belite Bio pivots toward commercialization.

A Chinese firm's 'Global Pioneer' status in cellular essence sparks debate on the future of biotech in cosmetics, medicine, and global regulation.

Shareholder approval paves the way for cancer therapy innovator VERAXA to go public, aiming to accelerate its next-gen antibody-drug conjugate pipeline.

The FDA has greenlit Ascendis Pharma's once-weekly YUVIWEL for achondroplasia, a major step for patients that also carries significant business implications.

In a radical pivot, diagnostics firm OpGen has become CapForce, an AI-powered investment bank targeting a $10B niche. Can it trade microbes for money?

Biotech firm NurExone showcases its CNS injury platform at key conferences, but the exit of its US subsidiary's CEO casts a shadow on growth plans.

Facing delisting for being a 'public shell,' XTL Biopharma plans an appeal while its new acquisition and valuable IP hang in the balance.

The biotech firm's stock surged after announcing a massive share repurchase, a bold move balancing shareholder value with its high-stakes R&D pipeline.

The stars join The Elizabeth Taylor AIDS Foundation to modernize laws from the '80s that criminalize HIV status, clashing with modern science.

A new partnership is building an ultra-low temp supply chain, paving the way for the first off-the-shelf stem cell therapies for pets with chronic disease.

European biotech leader Hifas da Terra launches in the US, aiming to disrupt the mushroom supplement industry with its unique focus on clinical trials.

With U.S. cancer centers tripling adoption of its targeted drug delivery device, RenovoRx signals a potential shift in treating solid tumors.

On Rare Disease Day, Polaryx Therapeutics advances a novel oral drug in a pivotal trial for four devastating pediatric disorders, offering a new strategy.

After securing its Nasdaq spot, TuHURA Biosciences shifts focus to its promising immuno-oncology pipeline, aiming to tackle cancer treatment resistance.

The organ transplant innovator's massive Q4 profit came from a tax rule, but it signals a major turning point and confidence in long-term profitability.

A key European panel recommends Dupixent for children with chronic hives, offering a potential first-of-its-kind targeted therapy for a difficult condition.

A new oral therapy, mavorixafor, receives a key recommendation in Europe, offering a beacon of hope for patients with a debilitating ultra-rare immune disorder.

Tectonic Therapeutic reports key clinical progress in two distinct rare diseases, backed by a strong cash position and new leadership for its next phase.