The U.S. FDA is launching a program under which its commissioner can issue vouchers to companies he finds are aligned with ...

The US Food and Drug Administration announced a new national priority voucher plan that aims to cut drug review times to one ...

Aldeyra had received 2 complete response letters (CRL) from the FDA in April 2025 and November 2023 for past submissions.

The FDA's new genAI-assisted scientific review technology, named Elsa, was officially adopted by the agency on 2 June.

Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted ...

The Commissioner’s National Priority Voucher can be used by drug developers to participate in a novel priority program for ...

The investigational MRI contrast agent, gadoquatrane, is designed to deliver effective imaging at a significantly reduced ...

The program will bring together experts from across the FDA for a team-based review, rather than having an application move ...

FDA Commissioner Martin Makary, MD, shared his vision for a “New FDA” with biopharma leaders attending BIO in Boston.

Chemistry falls under the umbrella of natural sciences, alongside other fields like biology, geology and physics. Chemistry ...

The FDA launched a new Priority Review program, as uncertainty persists for the existing programme for paediatric disorders.