Author name: Leonardo Arias

The FDA advised IO Biotech last year to hold off on filing an approval application for its cancer vaccine Cylembio, pointing to a failed Phase 3 study in frontline advanced melanoma. The biotech has now gone under.

The FDA in January asked Amgen to pull Tavneos from the market, citing liver toxicity issues that affected the drug’s overall risk-benefit profile. The pharma refused.

While peptides are currently the dominant approach to GLP-1 agonism, Ambrosia Biosciences is pursuing a small-molecule approach.

Biogen, Eli Lilly, Merck and Novartis spent more than $20 billion to absorb biotechs with promising or approved drugs; the rare disease space notched approvals for therapies from Denali Therapeutics, Rocket Pharmaceuticals and Biogen; and Wave’s stock lost half its value after its RNA-based obesity candidate failed to impress investors.

Thousands of employees of the Department of Health and Human Services were fired last spring. Their colleagues are still picking up the pieces.

The agency is embarking on major initiatives — including helping states implement Medicaid work requirements — with fewer workers in the wake of the federal government’s restructuring, experts say.

Former device leaders said a culture of “fear and anxiety” has driven experienced staff from the Food and Drug Administration. An overburdened workforce has affected communications from the agency.

El aumento de la concentración de dióxido de carbono (CO2) en la atmósfera constituye uno de los principales retos ambientales actuales. Además de su contribución al cambio climático global, niveles elevados de este gas en espacios interiores —como ofi …

Unos científicos han desarrollado una nueva tecnología que permite hacer algo que hasta ahora era inviable: generar mapas geoquímicos de alta resolución desde el aire.   La nueva tecnología ha sido desarrollada por el equipo de investigación en Instru …

Kepler-51 es una estrella ubicada a 2615 años-luz de la Tierra. Esa estrella tiene cuatro planetas conocidos, al menos tres de los cuales son planetas del todo inusuales: su densidad es bajísima. Estos tres mundos superesponjosos tienen aproximadamente el tamaño de Saturno pero …