FDA Approval

Kenai Therapeutics hires a Novartis M&A veteran as CBO, signaling an aggressive strategy to advance its groundbreaking iPSC cell therapy for Parkinson's disease.

After a pivotal trial failure, Alector will present its new strategy at a key health conference, focusing on its innovative brain-delivery platform.

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.

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.

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.

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

A breakthrough cell line shows a two-fold increase in viral vector quality, a key step in making gene therapies more effective, safer, and accessible.

Annexon Biosciences spotlights its novel C1q inhibitor, Vonaprument, aiming to be the first therapy to preserve vision in geographic atrophy patients.

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.

NRx Pharmaceuticals gets a green light from the FDA to seek broader approval for its ketamine drug, NRX-100, using a novel real-world evidence approach.

With a key depression drug nearing Phase 3 and more data imminent, AtaiBeckley is set to make its case to Wall Street at three major March conferences.

With a bolstered cash runway from recent funding, Inventiva is all-in on its MASH drug, lanifibranor, racing against giants in a multi-billion dollar market.