After a short delay and concerns of potential intervention from senior officials, the FDA has issued a draft guidance for the industry on the potential use of minimal residual disease (MRD) and ...

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

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

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and ...

Torous noted that over the summer, a company called WHOOP received an FDA warning letter over a product that could measure ...

The administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for the upcoming financial year. The list of draft documents touches on many topics ...

In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...

Investing.com -- Legend Biotech Corp (NASDAQ:LEGN) stock rose 5.7% following the FDA’s release of draft guidance endorsing ...

The Food and Drug Administration is out with a list of guidance documents related to food it expects to publish over the next year, addressing issues ranging from the safety of gene-edited plants and ...