Author name: Leonardo Arias

Healthcare doesn’t have an AI experimentation problem. It has an execution gap — and that gap is widening.

While recent FDA guidance speaks to the agency’s support of innovative trial designs—including the use of external controls—the application of this flexibility appears to be inconsistent. One former regulator says the situation is more nuanced.

The upcoming FDA decision for Replimune’s advanced melanoma drug could be a litmus test for the agency’s future regulatory decision-making, analysts say, with implications stretching well beyond one company.

Nobel laureate Sir Michael Houghton and colleagues at Applied Pharmaceutical Innovation (API) outline how rigorous early testing, smart IP and regulatory planning, and scalable CMC choices can help founders reach first-in-human faster.

The Trump administration is requesting about $111 billion in discretionary funding for the HHS, nearly $16 billion less than its budget in 2026.

Regulators cut almost a dozen metrics that factor into the quality ratings and reverted back to an older and more generous bonus system. MA plans will get more than $18 billion in additional payments over the next decade as a result.

Lawmakers are considering bills that would unwind the state’s oversight over Ballad, a large state-sanctioned hospital monopoly. The FTC argues that’s a bad idea.

The remanufacturer said it now has a total of four clearances for Intuitive Surgical da Vinci instruments from the Food and Drug Administration.

Scientists, clinicians and residents of communities near medical device sterilization plants called for the EPA not to weaken its oversight of ethylene oxide in a public hearing.

Después de una serie de comprobaciones técnicas y maniobras, la nave Orión de la NASA y los cuatro astronautas que lleva a bordo han salido de la órbita terrestre y han puesto rumbo a la Luna, mediante una maniobra propulsiva clave conocida como encendido de inyecci&oacut …