Machina Medical, Corp. today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for ...

In 2025, the U.S. Food and Drug Administration (FDA or the Agency) issued a surprising number of enforcement letters to ...

Executives and investors in Thousand Oaks-based immunotherapy company Atara Biotherapeutics Inc. were left reeling last week ...

The FDA believes that data on MRD and complete response can expedite new drug delivery compared with long-term survival ...

Drew & Jonathan call out a design trend they believe seriously needs to go.

Recently, the U.S. Food and Drug Administration (FDA) issued a guidance document entitled Use of Real-World Evidence to Support ...

Recent advances in nanomedicine have brought significant improvements to drug delivery systems, yet persistent hurdles remain, including poor targeting, ...

The New York-based company, previously known as VantAI and incubated at Roivant before a spinoff, is working in a ...

In A Nutshell • A brain stimulation device cleared by the FDA in 2019 failed to beat placebo in a rigorous 150-participant ...

The collaboration marks a turning point in AI-driven drug design and trial forecasting, de-risking the drug development ...

In the draft guidance, the agency discusses how sponsors can leverage MRD and complete response rates as near-term efficacy measures and speed new therapies to market.

Less than four months after rejecting Sentynl Therapeutics and Cyprium Therapeutics’ treatment for Menkes disease, the FDA ...