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.

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 ...

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

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

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.

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

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

In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy associated with Duchenne muscular dystrophy. The decision comes after CBER ...

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

In this episode presented by Eclipsebio, BioSpace's head of insights Lori Ellis discusses mRNA and srRNA with Andy Geall of ...