By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...

Replacing animal testing with alternate methodologies in preclinical drug trials holds potential for the development of ...

FDA orphan designation for zenocutuzumab‑zbco targets NRG1 fusion–positive advanced cholangiocarcinoma, a small molecular subset within an aggressive malignancy with <15% five-year survival. Orphan ...

The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit requests to take part in the program. Companies are limited to one submission ...

Established drugs were repurposed, “me-too” drugs were approved, and even the few new biological approaches lacked clinical ...

The Food & Drug Administration is easing some of its guidelines on what can be labeled as having "no artificial colors." In a ...

The FDA Center for Drug Evaluation and Research has accepted a letter of intent for the first biomarker for idiopathic pulmonary fibrosis into its Biomarker Qualification Program, according to a press ...

The Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) today released the sDHT Adoption Navigator, a comprehensive educational resource designed to help ...

The large molecule drug substance CDMO market is projected to grow at a CAGR of approximately 9% over the forecast period. This growth is primarily driven by the rising demand for biologics and ...

The U.S. Food and Drug Administration on Sunday began accepting requests to participate in its PreCheck pilot program, designed to boost domestic drug supply by speeding up construction and review of ...

On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, ...

On February 1, 2026, the Food and Drug Administration (FDA) officially started accepting requests to participate in the FDA PreCheck pilot ...