Author name: Leonardo Arias

In a drastic decision made outside of its typical review process, the agency declared it would recommend 11 childhood shots going forward, down from 17.

While Zenas’ obexelimab hit the primary endpoint in the Phase III INDIGO study, it came far below the efficacy threshold set by Amgen’s B cell depleter Uplizna, approved by the FDA for IgG4-related disease last April.

Last month, the FDA declined to approve Sanofi’s tolebrutinib for a specific form of multiple sclerosis. In a recently published complete response letter, the agency detailed its reasoning behind the rejection.

OncoNano’s platform, called ON-BOARD, packages drugs in pH-sensitive micelles that ensure their specific delivery near tumors, while also preventing systemic exposure.

  Con el reciente aumento de Bitcoin hasta los $92,000, el mercado de criptomonedas se perfila para un potencial explosivo de ganancias. Sin embargo, la fuerte volatilidad que experimentó el mercado de criptomonedas en el cuarto trimestre de 2025 ha disuadido a muchos inversores, difi …

After a strong open to the year, the public markets suffered a six-month drought that led to biotech’s tightest IPO window in years.

Next-generation automation is closing the gap between curative science and real-world demand, enabling faster development, global consistency and broader patient access to CAR T therapies.

Industry leaders are focused on the resilience of key starting material supply and the knock-on effects of automation in the new year.

In a year that saw advisory committees placed under a particularly bright microscope at the FDA, the agency held fewer meetings than usual and agreed with its advisors only 57% of the time, Jefferies reported.

Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.