The FDA has accepted for Priority Review the BLA for tividenofusp alfa for the treatment of Hunter syndrome, also known as MPS II.

Neha Anand, Analyst, Biopharma Intelligence Services, Citeline, explains how the approval of Embrelis marks a pivotal moment ...

Researchers recommended that regulators consider mandating head-to-head trials comparing next-in-class and against existing in-class agents when possible.

Symvess (acellular tissue engineered vessel-tyod) was approved in the extremity vascular trauma indication by the Food and Drug Administration (FDA) in December 2024.

Breakthrough Therapy Designation granted to elironrasib for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer who have received prior ...

The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...

Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical firm pioneering therapies delivered through the suprachoroidal ...

Discovered and developed by Sarepta Therapeutics, Elevidys is a gene therapy that won accelerated approval in June 2023 and ...

A Mayo Clinic study confirmed the accuracy of a new FDA-approved blood test for early detection of Alzheimer's disease.

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

Borrello is one of several lawmakers introducing a bill in Albany, mandating schools at least have these anti-choking devices ...

Savara faces an FDA setback for Molbreevi, its aPAP treatment. Learn how the company plans to recover and file a new BLA by ...