FDA Approval

With pivotal data imminent for its blockbuster hopeful AXPAXLI, Ocular Therapeutix faces a critical month of investor meetings amid commercial headwinds.

Swiss biotech AC Immune begins a human trial for an oral drug aiming to halt the chronic inflammation driving diseases like Alzheimer's and Parkinson's.

A pivotal trial for a rare muscle disease failed its main goal, but promising data in a specific patient group offers a new, complex path forward.

Avacta's pre|CISION therapy shows faster, more potent, and more selective tumor targeting than Enhertu in an AI-driven study, paving the way for 2026 trials.

With a new CEO and a key investor conference ahead, Metagenomi bets on its unique metagenomics platform and a hemophilia drug to navigate a tough market.

ITF Therapeutics will unveil 10 new data presentations on its Duchenne therapy, DUVYZAT, offering critical new insights on long-term safety and efficacy.

C4 Therapeutics begins a crucial study for its oral protein degrader, cemsidomide, offering new hope for heavily treated multiple myeloma patients.

Arrotex secures rights to an innovative, FDA-approved nanotech eye drop, promising faster, simpler recovery for thousands of surgical patients.

New data on leronlimab reveals striking long-term survival signals in heavily pretreated mTNBC patients, hinting at a new way to fight the disease.

INmune Bio will present key Phase III results for CORDStrom, a systemic cell therapy for the devastating rare skin disease RDEB. Will it be a breakthrough?

Klothea Bio's trial for a 'longevity protein' drug in Honduras pushes the boundaries of science, but raises questions about offshore research and equity.

With BRINSUPRI revenues set to hit $1B, Insmed is pouring cash into a high-stakes pipeline. Can it outrun its massive burn rate to deliver the next breakthrough?

Early data on YOLT-202 shows it can safely restore normal protein levels in patients with Alpha-1 Antitrypsin Deficiency, a major step toward a cure.

With major grants from top foundations, Lario Therapeutics expands its precision neuroscience platform, offering new hope for complex neurological disorders.

Early data reveals a novel immunotherapy, STC-1010, may activate the immune system against a common, treatment-resistant form of colorectal cancer.

A groundbreaking, NIH-funded trial will use advanced PET imaging to test new Alzheimer's drugs, with XingImaging managing the critical visual data.

AVEO Oncology's ficlatuzumab advances in a pivotal Phase 3 trial, offering new hope for patients with a difficult-to-treat form of head and neck cancer.

Positive early trial data for ZP9830 shows promise for a new class of targeted autoimmune therapies, marking a strategic pivot for Zealand Pharma.

An independent board again backs the safety of BriaCell's metastatic breast cancer therapy in a pivotal Phase 3 trial, boosting hope for a new treatment.

Cyclerion's novel therapy for treatment-resistant depression, using EEG-guided anesthesia, gains key FDA support and a top-tier advisory board.