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

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

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

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 ...

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

Only with the adoption of digital imaging and AI-powered analysis will next-generation precision oncology therapies reach their full potential and ensure no eligible patient is overlooked.

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

The deal gives AstraZeneca’s rare disease unit Alexion access to specialized capsids developed by the Japanese biotech JCR ...

The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...

The approval of Moderna's Spikevax for kids at higher risk of contracting the disease continues the company's regulatory ...

Partners Ultragenyx and Mereo BioPharma saw their stocks drop by 21% and 30%, respectively, after announcing that the Phase ...