On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical ...

On January 6, 2026, the US Food and Drug Administration (FDA) issued two revised guidance documents relating to general ...

For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...

M4Q (R2) is a globally harmonized framework for structuring quality information in medicinal product registration ...

AI-powered medical wearables and software are flourishing following the FDA’s new hands-off regulatory guidance.

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

The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...

There is a consensus emerging that surgery is most appropriate for people with severe obesity for whom lifestyle ...

Carvykti sales surge, MRD FDA guidance speeds label expansion, and strong cash runway. Click for more on LEGN stock.

In certain cases, regulators will now be open to clearing therapies based on their ability to eliminate tumor cells, a change ...

For more than 60 years, this blank slate approach has been the Food and Drug Administration’s gold standard — and for good ...

The company also stands to gain from recent regulatory FDA guidance aimed at streamlining the development of non-opioid ...