The personalized mRNA cancer vaccine developed with Merck reduced melanoma recurrence by 42% in the INTerpath-001 trial presented at ESMO, though leaked results

Positive Phase 3 data for Genmab's recently acquired bispecific antibody suggest it could become a new standard of care in head and neck cancer, adding more tha

Lilly's experimental retatrutide posted roughly double the weight loss of Ozempic in a direct comparison, potentially setting a new bar in the obesity drug mark

The draft guidance would let a single approval cover multiple personalized gene-editing treatments, aiming to speed access for rare disease patients.

GSK's hepatitis B therapy won approval as a functional cure, a rare milestone for the chronic viral infection.

Early mRNA vaccine results in pancreatic cancer showed immune responses, extending the platform's reach after its melanoma readout.

The Trump administration granted enforcement discretion for six peptides that won a contested adviser recommendation, over career FDA staff concerns.

The company discontinued its sole asset after a mid-stage Alzheimer's trial failed, leaving its pipeline empty.

Iovance amended its lung cancer study for its tumor-infiltrating lymphocyte therapy, sending the biotech stock sharply lower.

Pharmacy benefit managers will have to share fee and compensation data with self-funded employer clients; employers praised the rule while PBMs called it overre

The merger combines the two biotechs to advance a rare skin-disease therapy, with up to $300 million tied to milestone payments.

The approval marks the first treatment for the rare neurological disorder, following a family-led effort to fund the gene therapy's development.

The partial hold affects two Gilead CAR-T studies, adding a regulatory setback for its cell therapy pipeline.

China's lower-cost, faster clinical trial system is reshaping how global pharma companies develop drugs.

The savings will be reinvested into research and development as the pharma looks to offset patent expirations.

Etiome, Cellarity and Empress Therapeutics were combined into a single AI-aided drug developer claiming better prediction of how medicines perform in humans.

The San Diego biotech is one of several companies developing cell therapies that could slow or halt Parkinson's disease.

The licensing deal hands BioMarin rights to a Fabry disease candidate from the two Korean drugmakers.