The labeling updates address the risk of early-onset toxicity, including life-threatening adverse events in patients with DPD ...
Complete DPD deficiency markedly impairs 5-FU catabolism, increasing risk of early severe diarrhea, mucositis, neutropenia, ...
In a new draft guidance issued on January 14, 2026, the FDA discussed the use of a modern statistical methodology in clinical trials designed to ...
The US Food and Drug Administration turned down a self-administered version of AstraZeneca Plc’s lupus medicine, but the UK drugmaker said it’s still working with regulators to advance the request.
The effort by FDA Commissioner Marty Makary, MD, MPH, to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the agency, stoking worries ...
Add Yahoo as a preferred source to see more of our stories on Google. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29 ...
The FDA rejected AstraZeneca's subcutaneous Saphnelo application, delaying U.S. approval until 2026, despite positive ...
On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support (CDS) ...
A Democratic lawmaker is raising new concerns about a Food and Drug Administration program designed to drastically shorten ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
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