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 ...

FDA approval of VYKAT XR for hyperphagia in Prader-Willi Syndrome marks a major milestone for Soleno Therapeutics.

The Supreme Court ruled on Friday that a challenge by retailers to the Food and Drug Administration’s denial of an ...

Archeus hopes to begin a Phase I trial of the PSMA-targeted agent in metastatic, castration-resistant prostate cancer later this year.

For selected applicants, the agency plans to cut review times down to one to two months and provide "tumor board-style" ...

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

Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...

On Tuesday, the U.S. Food and Drug Administration announced a new initiative to offer expedited reviews for new medicines, an ...

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

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