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

Revuforj is designed to treat patients with relapsed or refractory mutant NPM1 acute myeloid leukemia. The application has been assigned a real-time oncology review, which allows for a more efficient ...

JB Chemicals & Pharmaceuticals announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Amitriptyline ...

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

In announcing his new Commissioner's National Priority Voucher (CNPV) program, FDA Commissioner Marty Makary, MD, MPH, ...

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 ...

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

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

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 ...

The FDA announced a new national priority voucher plan that aims to cut drug review times, while Headspace launches direct-to ...