Gene therapy experts and advocates warning of the sector’s many challenges found a receptive audience in FDA leadership at a ...

Trump health officials signal eased FDA rules for rare disease gene therapy, but concerns linger over safety, oversight, and ...

In a roundtable event on Thursday, HHS Secretary Robert F. Kennedy Jr. said his office will work to eliminate barriers that ...

During an FDA panel discussion, the US health secretary prioritised easier routes to market for curative therapies.

The HHS secretary said people should have access to experimental therapies including unregulated uses of stem cells. But some ...

Voyager struggles with a negative enterprise value, financial risks, and limited catalysts in a competitive Alzheimer's ...

New first-line therapy for HER2-positive metastatic breast cancer shows promising results in clinical trial data.

Trump administration health officials assured drugmakers and researchers at a roundtable hosted by the FDA that they want to ...

Sarepta is the first company to publicly disclose that it's received the designation, for which the FDA had issued a draft guidance last year.

From 2020 to 2024, universities contributed patents underpinning 50% of FDA-approved drugs. 87% of those academic ...