More than thirty years since its 1993 founding, Catherine Owen Adams and Elizabeth Thompson—the R&D combo that has led Acadia ...

The FDA cited manufacturing issues but did not flag problems with Ultragenyx’s data package for UX111, with the biotech ...

Only with the adoption of digital imaging and AI-powered analysis will next-generation precision oncology therapies reach ...

The drug came to AstraZeneca through its acquisition of CinCor Pharma in 2023, with the hopes of beefing up its ...

Through its recently unveiled Priority Voucher program, the FDA seeks to accelerate the review process for companies that ...

Despite the FDA commissioner’s promises of partnership and collaboration, personnel changes and continued federal cuts create ...

Takeda’s oveporexton improved wakefulness, attention and other key narcolepsy endpoints “with a high degree of statistical significance,” according to Jefferies analysts.

The development saga for the depression molecule has been rocky for years, unable to ease symptoms in multiple late-stage trials.

Market reaction to recent readouts from Compass Pathways and Beckley Psytech/atai in treatment-resistant depression speaks to ...

New data and analyses presented at the American Diabetes Association’s annual meeting highlight the priorities for the next ...

Leerink Partners called the announcement a ‘positive’ given the delayed timeframe and the uncertainty that the administration ...

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...