Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications ... of our editorial content, we keep a strict ...

Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose regimen of nusinersen to advance the treatment of SMA ...

The contents section serves as a navigational ... products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced ...

With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...

To tackle a backlog in toxicity testing, US federal scientists are modernizing programs with high-throughput assays and AI.

Conclusions Wider use of adaptive designs will necessitate new drug application sponsors to engage with regulatory scientists during planning and conduct of the trials. Investigators need to more ...

The field of reproductive science has witnessed remarkable strides in recent years, offering new hope and possibilities to individuals and couples seeking to overcome fertility challenges. From ...

Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on ...

A team of scientists has developed a groundbreaking approach using specially designed peptides to improve drug formulations.

Discover the potential of macrocycles in drug discovery: flexible, cell-permeable molecules targeting undruggable proteins.

Discover how precision medicine and FDA's Project Optimus are transforming clinical trials in oncology drug development.