Building FDA submissions like a solid house requires early collaboration, proactive planning, and a clear regulatory story.

Peter Greene, actor known for 'Pulp Fiction' and 'The Mask,' dead at 60 Do 1 Small Thing in Every Conversation to Be Instantly Likable, Says Communications Expert MacKenzie Scott announced another ...

A dozen prior leaders of the U.S. Food and Drug Administration have issued a scathing denunciation of an FDA memo to staff ...

The drugs are essentially laboratory-made versions of natural antibodies that help the immune system fight off RSV. The FDA ...

Federal regulators have begun a safety review of two RSV medicines used to protect infants, even though no safety problems ...

The U.S. Food and Drug Administration warned people to stop using certain types of glucose monitor sensors that were linked ...

An incident in Denver that started with a drug-induced psychotic episode and ended with the largest single-location insurance ...

The FDA expands COVID vaccine death review to include adults amid ongoing vaccine safety evaluations and political scrutiny.

FDA inspection documents reveal systemic contamination issues at ByHeart formula plant as botulism outbreak sickens 37 ...

A 32‑year‑old man suffering from a drug‑induced breakdown caused chaos at an apartment in Soi Kor Phai, South Pattaya, on the ...