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.

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

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

The initiative, referred to as the Commissioner’s National Priority Voucher program, allows drug developers to participate in a novel FDA priority program. The program significantly shortens the FDA ...

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

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

“Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the ...