Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

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

Raleigh-based Focal Medical, an oncology device company that received early funding from the North Carolina Biotechnology Center, has been acquired by a Florida biopharmaceutical company. Financial ...

Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing next-generation CAR T-cell therapies for patients with cancer, today announced that it has entered into a securities ...

John Burke, MD, discusses his editor-in-chief column from the July 2025 issue of Targeted Therapies in Oncology.

A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...

Jyong Biotech targets urinary disorders with a novel botanical pipeline, but clinical and liquidity risks temper near-term ...

A tiny flower-shaped particle could help to pave the way for a new treatment approach to Alzheimer's and Parkinson's that targets the root causes.

Industries are embracing these geometric shapes, which were imagined in 1970 by a NASA scientist. Decades later, they have ...

The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...

Children as young as six months are exposed to adult cosmetics. Risks include hormone disruption, skin reactions and ...