The company plans to meet with the FDA to discuss a rolling approval application for “COMP360,” a synthetic form of psilocybin that could become the first “classic” psychedelic cleared for the U.S.

Investors were looking for a greater difference between Ocular’s experimental medicine and a low-dose version of Eylea, ...

As the CGT market evolves, developers must answer one key question that will shape their manufacturing strategy: “Should we go with a modular platform or a fully integrated system?”  Both approaches ...

Sales of Casgevy, a gene-edited treatment developed with CRISPR Therapeutics, more than tripled compared to the third quarter, a performance analysts saw as a bright spot in Vertex's report.

Lyell’s trial will test its experimental cancer cell therapy directly against marketed counterparts. Elsewhere, Biogen swapped board chairs and venture firms are joining up at a “pivotal time” for ...

Another FDA knockback for a gene therapy has investors and analysts redrawing expectations for the rare disease drug developer.

The mRNA specialist reiterated its financial estimates for 2026 amid a challenging U.S. regulatory environment where its influenza vaccine just hit a major setback.

The FDA has lifted longstanding and the most severe warnings off of hormone replacement therapies for menopausal women.

The latest in a string of clinical wins, the late-stage data gives the company strong footing to compete with BioMarin's top seller.

Neurocrine and Alnylam each face investor questions about the growth potential of key franchises. Ascendis, meanwhile, saw an ...

The microbiome specialist, which for years has struggled to stay afloat, is cutting its staff by 30% and focusing resources on earlier, immunology-focused research.

The move drew skepticism from investors despite multiple recent research setbacks that have left questions about Sanofi’s ability to confront Dupixent’s looming patent expiration.